Merck Serono Has Requested Re-examination Of The CHMP Opinion For Erbitux In Non-Small Cell Lung Cancer

Merck Serono, a division of Merck KGaA, Darmstadt, today announced that it has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the 1st-line treatment of patients with non-small cell lung cancer (NSCLC). Taking the opinion seriously Merck Serono will work closely with the CHMP to unravel the value of Erbitux for patients benefit most.

Merck Serono’s decision to request re-examination follows consultation with key stakeholders in the NSCLC treatment community, coupled with its confidence in the clinical data supporting Erbitux in this potential indication.

Based on the Phase III study FLEX Erbitux has been acknowledged in the oncology academic community:

- The data from the FLEX study were presented in the plenary session during the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) – the worldwide leading cancer congress2

- The Journal of Clinical Oncology named Erbitux as one of the major research advances in this difficult-to-treat cancer3

- Erbitux is already recommended for the 1st-line therapy of NSCLC by US Clinical Practice Guidelines issued by the independent National Comprehensive Cancer Network (NCCN)4

- A recent publication in one of the leading medical journals in Europe, The Lancet, concludes that Erbitux “added to platinum-based chemotherapy can be regarded as a new standard 1st-line treatment option for patients with EGFR-expressing advanced non-small cell lung cancer”1

About FLEX

In the randomized, multinational, Phase III FLEXa study, the overall survival was significantly prolonged for patients receiving Erbitux in 1st-line therapy. The FLEX study included a patient population (1,125 patients) comprising all histological NSCLC subtypes, who received either standard platinum-based chemotherapy plus Erbitux, or chemotherapy alone. Adding Erbitux to chemotherapy significantly prolonged median overall survival regardless of histology, compared to chemotherapy alone (11.3 vs. 10.1 months, respectively; p=0.04). Across the study population, the addition of Erbitux to platinum-based chemotherapy was tolerated with manageable side effects.1

For such a broad patient population, Erbitux is the first and only new targeted compound in clinical development in more than 10 years to increase overall survival.

About lung cancer

In Europe, lung cancer is the leading cause of death from cancer – 20% of all cancer deaths (28% in men and 10% in women).5 NSCLC accounts for approximately 80% of all lung cancer cases.6 At diagnosis, most patients with NSCLC present with advanced, inoperable (unresectable) disease, which is associated with a very poor prognosis.7 The overall 5-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.8

Merck submitted an application to the European Medicines Agency (EMEA) to license Erbitux for 1st-line treatment of NSCLC in September 2008. The CHMP opinion was published on the EMEA website on July 24, 2009. Erbitux is currently a 1st-line treatment for both metastatic colorectal cancer (mCRC) in patients with KRAS wild-type tumors and squamous cell carcinoma of the head and neck (SCCHN).

aFLEX: First-Line ErbituX in lung cancer


1. Pirker R, et al. Lancet 2009;373:1525-31.
2. Pirker R, et al. ASCO 2008;Abstract No: 3.
3. Winer E, et al. J Clin Oncol 2009;27:812-26.
4. NCCN. nccn/professionals/physician_gls/PDF/nscl.pdf
5. European Lung Foundation. european-lung-foundation/index.php?id=65.
6. D’Addario G & Felip E. Ann Oncol 2008;19(Suppl 2):ii39-40.
7. Bunn PA & Thatcher N. Oncologist 2008;13(Suppl 1):1-4.
8. Sant M, et al. Ann Oncol 2003;14(Suppl 5):v61-118.

Merck Serono

View drug information on Erbitux.

Arthritis Relief – Gastrointestinal Damage Less Likely With Celecoxib Than Diclofenac/Omeprazole (CONDOR Study)

Patients receiving a NSAID (non-selective non-steroidal anti-inflammatory drug) as well as a PPI (proton pump inhibitor) – to treat inflammation and pain in arthritis – are more than four times more likely to suffer upper or lower gastrointestinal adverse clinical outcomes compared to those receiving a cyclo-oxygenase (COX)-2 selective NSAID.

The findings of the CONDOR study, reported in an Article Online First in the medical journal The Lancet, should encourage review of approaches to reduce risk of NSAID treatment. The study is Professor Francis K L Chan, Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong Special Administrative Region, China, and Professor Jay Goldstein, University of Illinois at Chicago, IL, USA, and colleagues. The study is being presented at the European League Against Rheumatism (EULAR) Annual Conference in Rome.

Previous studies have demonstrated that COX-2-selective NSAIDs and non-selective NSAIDs plus a proton-pump inhibitor (PPI) have comparable side effects in the upper gastrointestinal tract, but adverse effects in the entire gastrointestinal tract (including the lower part) might be less common with selective drugs than with non-selective drugs. This is because acid suppression does not avert damage to the lower gastrointestinal tract. In this study, the scientists aimed to compare risk of gastrointestinal events associated with celecoxib (COX-2 selective NSAID) versus diclofenac slow release (a non-selective NSAID) plus omeprazole (a PPI).

This randomised trial recruited patients with osteoarthritis or rheumatoid arthritis at increased gastrointestinal risk, that is, aged 60 years or over, or 18 years and older with previous gastrointestinal ulceration.

The study involved 196 centres in 32 nations or territories. Patients tested negative for Helicobacter pylori (a risk factor for peptic ulcer). Patients were assigned in a 1:1 ratio to receive celecoxib 200 mg twice a day or diclofenac slow release 75 mg twice a day plus omeprazole 20 mg once a day. Patients and researchers were masked to treatment allocation. The primary endpoint was a composite of clinically significant upper or lower gastrointestinal events adjudicated by an independent committee. Such events included several potential outcomes relevant to clinical practice, ranging from discontinuation of treatment due to presumed significant occult blood loss to admission to hospital for life-threatening complications.

4484 participants were randomly allocated to treatment (2238 celecoxib; 2246 diclofenac plus omeprazole) and were included in intention-to-treat analyses. 20 (0???9%) patients receiving celecoxib and 81 (3???8%) receiving diclofenac plus omeprazole met criteria for the primary endpoint, meaning those receiving diclofenac plus omeprazole were more than four times more likely to suffer upper or lower gastrointestinal adverse clinical outcomes than those in the celecoxib group. 114 (6%) patients taking celecoxib versus 167 (8%) taking diclofenac plus omeprazole withdrew early because of gastrointestinal adverse events.

The authors conclude:

Since guidelines recommend that selection of NSAID therapy be driven by consideration of both cardiovascular and gastrointestinal effects of treatment, CONDOR has provided new data relevant to patients requiring anti-inflammatory therapy who are at increased gastrointestinal but not increased cardiovascular risk. In this population, the gastrointestinal outcomes of a COX-2 selective NSAID were quite different to those of a non-selective NSAID plus a PPI. Further understanding of the cardiovascular outcomes of these two strategies requires the results of ongoing trials that have been designed directly to address that important clinical question. The findings of the CONDOR trial should encourage guideline committees to review their treatment recommendations for arthritis patients.

Dr Elham Rahme and Dr Sasha Bernatsky, McGill University, Montreal, QC, Canada, in an accompanying Comment wrote:

Chan and colleagues suggest that risk of lower gastrointestinal bleeding could be as important a consideration as is risk of upper gastrointestinal bleeding. However, decreased risk of gastrointestinal adverse events was driven mainly by haemoglobin decrease, not by documented lower gastrointestinal bleeds. Thus, although the researchers close by suggesting revision of existing guidelines (which currently recommend selection of anti-inflammatory therapy on the basis of the patient’s upper gastrointestinal and cardiovascular risks), this advice might be premature.

Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial
Francis K L Chan, Angel Lanas, James Scheiman, Manuela F Berger, Ha Nguyen, Jay L Goldstein
The Lancet, Early Online Publication, 17 June 2010

Accompanying Comment

NSAIDs and risk of lower gastrointestinal bleeding
Elham Rahme, Sasha Bernatsky
The Lancet, Early Online Publication, 17 June 2010

Edited by:

Alzheimer’s Society Comment On The Northwestern University ‘Super Ageing’ Project, Initial Observations

Dementia is caused by diseases of the brain and robs people of their lives. It is not a natural part of ageing, but age is the biggest risk factor.

This small study may be a stepping-stone to further research that helps us understand why some people retain good cognitive function in later life.

This research suggests that older people with good memory do not experience the same brain changes that develop in those with poor memory. Further research can build upon these findings and look specifically at the brain characteristics which enable people to stay healthy and sharp in later life.

Professor Clive Ballard
Director of Research
Alzheimer’s Society

Information about Alzheimer’s Society

Alzheimer’s Society is the leading care and research charity for people with all forms of dementia and their carers. It provides information and education, support for carers, and quality day and home care. It funds medical and scientific research and campaigns for improved health and social services and greater public understanding of dementia.

Alzheimer’s Society provides a national help line on 0845 3000 336 and website alzheimers. Please include this information in any publication that uses these comments.

Alzheimer’s Society

Simple test for ozone lung damage

A simple blood test may soon reveal the damage caused to lungs by the atmospheric pollutant ozone.

It is based on detecting levels of a protein, CC16, secreted by cells in the walls of tiny respiratory vessels called bronchioles.

Experiments have shown protein levels are higher- and lung damage higher – in people exposed to ozone.

The work, by University Hospital, Ume?, Sweden, is published in the European Respiratory Journal.

Previously the only way to assess lung damage caused by exposure to ozone was to take a tissue sample.

Not only was this more invasive, it appears not to be as sensitive as the new test.

Ozone at very high altitudes provides an essential protective shield against the sun’s dangerous ultraviolet rays.

However, it is also produced closer to ground level when sunlight reacts with pollutants spewed out by vehicle exhausts.

Breathed in it can aggravate chronic respiratory conditions, and it has been shown that during periods of particularly high ozone levels deaths and hospital admissions from respiratory disease increase.

Laboratory tests have also shown that ozone can led to inflammation of the lungs, and injury to the fine layer of epithelial cells that coat the airway surface.

These cells secrete CC16 as a way to try to minimise inflammation.


The new test is based on the theory that this protein leaks into the blood when the epithelial cells are damaged and thus form less of a protective barrier than usual.

Therefore, the more protein found in the blood, the greater the damage that has occurred.

The researchers monitored 22 healthy adults, who breathed in pure air, or air enriched with ozone during an exercise session.

Blood samples showed that CC16 concentrations in the blood were significantly higher after breathing the ozone mixture.

Conversely, CC16 levels were lower than normal after the volunteers breathed in air completely free from ozone.

The researchers hope that a test can be developed in the near future, but they warn that CC16 levels do vary from one individual to another, and even in the same individual at different times of day.

Lead researcher Dr Anders Blomberg said: ‘Clearly, this element will need to be taken into account when the biomarker is used to assess the impact of atmospheric pollution.

‘There is still plenty of work to be done, but we are making progress.

‘We should soon complete work on developing a specific mathematical model designed to take daily CC16 variations into account.’

Professor Malcolm Green, of the British Lung Foundation, told BBC News Online: ‘At present this is a research tool, and it appears that there are many influences on the level of this blood marker so that it is not possible to draw any conclusions from tests in particular individuals.

‘However, this is exciting and novel research which may well lead to a much deeper understanding of the effect of ozone on the lungs of people exposed to environmental pollution.’

Research May Unlock Mystery Of Autism’s Origin In The Brain

In the first study of its kind, researchers have discovered that in autistic individuals, connections between brain cells may be deficient within single regions, and not just between regions, as was previously believed.

Tony Wilson, Ph.D., lead researcher and assistant professor of neurology at Wake Forest University School of Medicine, said he hopes this study will eventually lead to earlier diagnosis and more targeted medications for autism.

Using magnetoencephalography (MEG) brain imaging technology to measure brain electrical activity, the researchers administered a test called the 40 hertz (cycles per second) auditory steady-state response test. The test measures electromagnetic wave cycles and indicates brain cell discharges at the 40 hertz frequency.

“This test measures the brain’s capacity to mimic what it’s hearing. A healthy brain’s cells will fire back at 40 hertz,” said Wilson. “We chose this test because it is a robust metric of how well individual circuits are functioning.”

The results were reported in this month’s issue of Biological Psychiatry.

A group of 10 children and adolescents with autism, and 10 without autism, listened to a series of clicks occurring every 25 milliseconds (ms) for a duration of 500 ms. The MEG measured the brain’s responses to these clicks.

In the right hemisphere of the brain, which controls attention and spatial processing, there was no significant difference in the groups. But the results showed a considerable discrepancy between the two groups in the left hemisphere, the area of the brain that controls language and logic.

In the auditory area of the left hemisphere, the group without autism delivered a brain response to the 40 hertz stimulation 200 ms after it began. However, the group with autism failed to respond entirely at the same 40 hertz frequency.

“Our results made sense. Both anecdotal and behavioral evidence suggest children with autism have significantly disturbed brain circuits on the local-level within an individual brain area,” said Wilson. “For example, they tend to restrict their visual gaze to a part of someone’s face, like a nose or an eye, but not the person’s whole face.”

The results also support previous research that showed disconnections between two or more brain regions, known as long-range connectivity. This new study supports the idea that the network as a whole is broken, but shows the disconnection in long-range connectivity may actually start within individual brain regions, known as local connectivity.

Wilson explains the difference between local and long-range connectivity using vision as an example. “With vision, one part of your brain identifies color, another perceives motion. Within each of these areas of your brain, there is local connectivity between brain cells that allow the region to do its job. When you see a red ball flying across the room, both of these areas of your brain start communicating with each other and put together flying and red as qualities of the same ball. That’s long-range connectivity.”

Wilson conducted the autism research while at the University of Colorado, but says he hopes to continue his autism research at Wake Forest.

“I chose Wake Forest because it has one of the most advanced MEGs in the country. Here, we can study the brain at a very precise level,” said Wilson.

Co-authors on this study were Donald Rojas, Ph.D., Martin Reite, M.D., and Peter Teale, M.S.E.E., with University of Colorado, and Sally Rogers, Ph.D., with University of California-Davis.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. U.S. News & World Report ranks Wake Forest University School of Medicine 18th in primary care and 44th in research among the nation’s medical schools. It ranks 35th in research funding by the National Institutes of Health. Almost 150 members of the medical school faculty are listed in Best Doctors in America.

Wake Forest University Baptist Medical Center
Medical Center Blvd.
Winston-Salem, NC 27157-1015
United States

Study Reveals Children Recover From Autism With Intensive Three-Year Behavioral Therapy

A landmark study proves that children are capable of recovery from autism, or of making substantial gains in cognitive and adaptive functioning, as well as language skills, according to results released last night by Dr. Doreen Granpeesheh, founder of the Center for Autism and Related Disorders, Inc. (CARD).

The three-year study, which the State of Arizona funded and CARD, the world’s largest provider of early intensive behavioral intervention for children with autism, conducted, evaluated the effects of behavioral intervention for 14 young children with autism using a version of Applied Behavior Analysis (ABA) that blends structured teaching with play-based behavioral intervention. Today, 43 percent of the study’s participants no longer display clinical symptoms of autism and most of the participants demonstrate significant improvements in functioning.

In accordance with previous research, CARD found that many of the children made substantial gains in cognitive and adaptive functioning, as well as language skills. Most of the children also demonstrated significant improvements in executive functioning. After treatment, the average T-score for the group on the BRIEF, a measure of overall executive functioning, was 61, well below the cut-off for clinically significant impairment. In addition, 8 out of 14 children were functioning in the average range on the Vineland ABC, a measure of overall adaptive functioning, whereas only 2 of 14 were in the average range before treatment began.

“Years ago, some doctors would tell parents that they should institutionalize their children after an autism diagnosis,” said Dr. Granpeesheh. “Today, we know that autism is treatable and recovery is possible with the right services. Every child deserves a chance to learn and grow, and we hope that these results provide hope to families of newly diagnosed children.”

Among the study’s major findings is that children who developed language skills early in therapy made greater gains over time. The children who did not recover from autism still made substantial gains in their abilities to communicate and live independently. Even the children whose progress was slowest experienced significant decreases in challenging behaviors and increases in independent communication and leisure skills, thereby resulting in improved self-reliance and quality of life.

“My daughter is now recovered from autism,” said Elizabeth Howell, parent of a study participant. “When people meet her and interact with her, they cannot believe that she ever had an autism diagnosis.”

All children in the study received 25 or more hours per week of one-on-one teaching and therapy. A careful assessment of each child’s strengths and deficits led to targeted teaching programs. Treatment plans were based on children’s motivations and activities were based on their interests.

“The behavioral intervention was intensive, comprehensive and high-quality,” said Dr. Amy Kenzer, CARD research manager. “These factors play a major role in the outcomes observed.”

Autism is a pervasive developmental disorder that is marked by the presence of impaired social interaction and communication and a restricted repertoire of activities and interests. Autism is estimated to affect as many as 1 in 110 children in America and is four times more common in boys than in girls.

Source: Center for Autism and Related Disorders, Inc

Mediterranean Diet Wards Off Childhood Respiratory Allergies

A “Mediterranean” diet rich in fruits, vegetables and nuts protects against allergic rhinitis and asthma symptoms, suggests research published ahead of print in Thorax.

The researchers assessed the dietary habits, respiratory symptoms, and allergic reactions of almost 700 children living in four rural areas on the Greek island of Crete.

The children were all aged between 7 and 18 years of age.

Skin allergies are relatively common in Crete, but respiratory allergies, such as asthma and allergic rhinitis are relatively rare.

Parents completed detailed questionnaires on their children’s allergic and respiratory symptoms and dietary habits.

Whether the children ate a “Mediterranean” diet was measured against a set of 12 foodstuffs, including fruits, vegetables, whole-grains, legumes, nuts, and olive oil.

Eight out of 10 children ate fresh fruit, and over two thirds of them ate fresh vegetables, at least twice a day.

The effect of diet was strongest on allergic rhinitis, but it also afforded protection against asthma symptoms and skin allergy.

Children who ate nuts at least three times a week were less likely to wheeze.

Nuts are a rich source of vitamin E, the body’s primary defence against cellular damage caused by free radicals. And they contain high levels of magnesium, which other research suggests, may protect against asthma and boost lung power.

And a daily diet of oranges, apples, and tomatoes also protected against wheezing and allergic rhinitis.

Grapes in particular seemed to protect against current and previous wheezing and allergic rhinitis, even after adjusting for other potentially influential factors.

Red grape skin contains high levels of antioxidants as well as resveratrol, a potent polyphenol, known to curb inflammatory activity, say the authors.

But high consumption of margarine doubled the chances of asthma and allergic rhinitis, the findings showed.

Protective effect of fruits, vegetables and the Mediterranean diet on asthma and allergies among children in Crete
Online First Thorax 2007; doi:10.1136/thx.2006.69419

Stop Flu At School Vaccination Clinics Begin, Hawaii

Just in time for the flu season, the Hawai’i State Department of Health (DOH) this week began administering free flu vaccine to thousands of Hawai’i elementary and middle school students statewide through the Protect Hawai’i’s Keiki: Stop Flu At School program. Three hundred thirty-eight school clinics are scheduled between October and December 2008.

More than 60,000 children are signed up to receive flu vaccine this fall through the program. Of participating students, approximately 53,000 attend public schools. Additionally, close to 7,000 teachers and school staff will receive the flu vaccine, pushing the total number of vaccinations near 70,000.

“We hope this program helps to remind everyone about the importance of getting their seasonal flu vaccine this year,” said Health Director Dr. Chiyome Leinaala Fukino. “The students and faculty participating in this program are a great example for all of us. Getting the flu vaccine is everyone’s best protection against the flu.”

“Following the success of last year’s program, we are excited to be offering the free flu vaccine to elementary and middle school students at their schools,” said Patricia Hamamoto, superintendent of Hawai’i public schools. “We anticipate that participation in the Stop Flu at School program will translate into fewer sick days and more quality learning time in the classroom.”

According to recent studies, school children vaccinated against flu have fewer illnesses, fewer absences from school, and lower rates of illness in their families during flu season, compared with unvaccinated children.

“We are encouraged so many parents and caregivers are taking advantage of this program so we can counter one of the biggest sources of flu transmission in our communities,” said State Epidemiologist Dr. Sarah Y. Park. “Our goal is to continue to build on this program in order to make our communities stronger and healthier.”

Stop Flu at School partners include the Hawai’i State Department of Health, Hawai’i State Department of Education, Hawai’i Association of Independent Schools, and Hawai’i Catholic Schools with support from the U.S. Centers for Disease Control and Prevention, Hawai’i chapters of the American Academy of Pediatrics and American Academy of Family Physicians, the Hawai’i Medical Reserve Corps, the University of Hawai’i Nursing Program, the Hawai’i Pacific University Nursing Program, UH Hilo Nursing Program, Kaua’i Community College Nursing Program, Maui Community College Nursing Program, MedImmune, Sanofi Pasteur, Kaiser Permanente, and the Hawai’i Medical Service Association (HMSA).

Information about the program for parents and caregivers is available online at stopfluatschool or by calling Aloha United Way’s 2-1-1 hotline.

Judy Kern
Communications Office
Hawai’i State Department of Health

Research Carried Out In Mice Will Contribute To The Study Of Hereditary Diseases That Lead To Blindness

Researchers of the University of Granada (Spain) have used a technique consisting of the induction of neuronal degeneration neuronal for intense light exposure in the mouse’s retina that will be helpful for the study of retinitis pigmentosa (RP), a group of hereditary diseases which lead to blindness and affect more than one million persons a year all over the world. In addition, the results of this research work could be very useful for the detection of new factors or molecules originated by microglial cells and related to degenerative processes of the retina.

The doctoral thesis of Ana Mar?­a Santos Carro, researcher of the Department of Cell Biology of the University of Granada, is based on the study of microglial cells, a type of cell of the Nervous System that develop a phagocytic or purifying role against damages or infections in such system. Her work has analysed the distribution of microglial cells in la retina of the mouse during all its development, both embryonic and postnatal and adult, and has studied the response of these cells to a neurodegenerative process induced in the retina by intense light exposure.

Parkinson’s and Alzheimer’s

The researcher of the UGR insists that “it is important to get to know the response of the microglial cells against neurodegenerative, because such cells are practically involved in all the diseases and damages of the nervous system, including Parkinson’s and Alzheimer’s, and knowing their behaviour in pathologic situations could be helpful in the design of therapeutic strategies”.

Microglial cells are the resident population of macrophages in the central nervous system (CNS) and play a relevant role in the immune defence. The research group of the UGR “Embryology of the Nervous System” has been studying for years the origin, distribution and migratory characteristics of these cells, both in situations of normal development of the healthy CNS and in response to damages or injuries using as a model of study the retina of birds and mammals.

The doctoral thesis of Ana Mar?­a Santos Carro has been supervised by Professors Miguel ??ngel Cuadros Ojeda, Julio Navascu?©s Mart?­nez and Jos?© Luis Mar?­n-Teva.

Part of the results of this research work has been recently published in the specialized Journal of Comparative Neurology. Likewise, some of the results obtained have been presented in oral communications and posters in different national and international scientific meetings: VIII European Meeting on Glial Cell Functions in Health and Disease (Londres), VII European Meeting on Glial Cell Functions in Health and Disease (Amsterdam), IV Meeting of the Spanish Glial Network (Madrid), etc.

Ana Mar?­a Santos Carro

University of Granada

Folate Deficiency Is Associated With A Three-Fold Increased Risk Of Dementia

Among elderly people, lower levels of folate can be associated with a
three-fold increase in risk for dementia, claims a study published in
the Journal of Neurology, Neurosurgery, and Psychiatry,
part of the British Medical Journal Specialist Journals, on February 5,

Folate, vitamin B12, and the protein homocysteine are involved in
reactions that are needed to produce several chemicals, including some
neurotransmitters, lipids, and nucleotides. Previously, studies have
shown a link between deficiencies in these chemicals and the prevalence
of dementia, however, the results have been controversial because of
the physical changes dementia often creates. High levels of
homocysteine have also been associated with cardiovascular disease.

In this study, the researchers followed 518 people over 2 years
(2001-2003), tracking the development of dementia within the
population. All participants were more than 65 years old and lived in
one rural or one urban area in the south of the country. To do this, at
the beginning and the end of the two year period, validated tests were
run to test for any dementing illness. Additionally, blood tests were
taken to assess folate, vitamin B12

blood tests were taken to assess levels of folate, vitamin B12, and
homocysteine levels, and the changes with time were observed. At the
beginning of the period, almost one in five participants showed high
levels of homocysteine, almost the same had low levels of vitamin B12,
and 3.5% were deficient in folate. Higher levels of folate were
associated with higher vitamin B12 levels and lower homocysteine.

At the end of the study, 45 of the participants had developed dementia.
Of these, 34 had been diagnosed with Alzheimer’s disease, seven with
vascular dementia, and four with “other” types of dementia. Dementia
showed more prevalence in older patients, in the relatively uneducated,
the inactive, and those with deposits of the protein ApoE.

Dementia onset was more likely in those who were older, relatively
poorly educated, inactive, and had deposits of ApoE, a protein
associated with the breakdown of lipids. It was also much more likely
in those whose folate levels fell further over the two years while
homocysteine levels increased. Individuals with folate deficiency at
the start of the study were at risk for dementia almost 3.5 times more
than others.

This suggests, according to the authors, that changes in micronutrients
such as folate could be linked with the other typical signs that lead
up to dementia, such as weight loss and low blood pressure. Weight loss
could indicate a dietary change in quality or quantity of food intake,
but it is unlikely to itself change the levels of micronutrients in the

Changes in folate, vitamin B12 and homocysteine associated
with incident dementia
J-M Kim, R Stewart, S-W Kim, I-S Shin, S-J Yang, H-Y Shin, J-S Yoon
Journal of Neurology, Neurosurgery, and Psychiatry
doi 10.1136/jnnp.2007.131482
Here For Abstract

Anna Sophia McKenney