Alzheimer's, Dementia & Mental Health
Placebo Wins and Bapineuzumab Bites the Dust in Quest to Conquer Alzheimer’s
Pfizer, Johnson & Johnson call it quits on joint venture with antibody that targets beta-amyloid
Aug. 7, 2012 – The placebo wins again in the struggle to find drugs to prevent or treat Alzheimer’s disease. The latest
victim is bapineuzumab in its intravenous form. Johnson & Johnson and Pfizer, partners in the clinical
trials, announced yesterday that phase 3 clinical development of bapineuzumab intravenous (IV) in patients with mild-to-moderate Alzheimer's
disease is being discontinued.
Bapineuzumab IV is an antibody that targets beta-amyloid (Aβ), a protein that can exert toxic effects in the brain and is
believed to play a central role in the pathology of Alzheimer's disease.
Game-Changing Find in Battle Against Alzheimer’s: A Gene Offers Protection
Study links cognitive decline in senior citizens with Alzheimer’s disease; says amyloid-beta plaque is cause of AD
July 12, 2012
Cognitive Decline in Seniors Not Slowed by Omega-3 Fish Oil in Short Term
But researchers say longer term effects of omega-3 on cognitive decline and dementia need to be explored; urge seniors
continue eating fish regularly
July 10, 2012
Tai Chi Enlarges Brains, Improves Memory, Thinking in Elderly Chinese
First trial showing lesser aerobic exercise, with stimulating discussion increased brain volume, improved results
on memory, thinking tests
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Obama Administration: A Plan To Prevent Alzheimer’s By 2025
Plan has been through months of
development since President Obama signed National Alzheimer’s Project Act
in January 2011, funding, however, an issue - see video - May 16, 2012
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Alzheimer's, Dementia & Mental Health
Janssen Alzheimer Immunotherapy (Janssen AI), a subsidiary of Johnson & Johnson, is a partner with Pfizer in the
Alzheimer's Immunotherapy Program (AIP). The Joint Steering Committee for the AIP has decided to discontinue the development of bapineuzumab
IV in mild-to-moderate Alzheimer's disease based on the co-primary clinical endpoints not being met in the Janssen AI-led Studies 301 and 302.
"While we are disappointed in the results of the two bapineuzumab IV studies, particularly in light of the urgent need
for new advancements in Alzheimer's disease, we believe that targeting and clearing beta amyloid remains a promising path to potential
clinical benefits for people suffering from this disease," said Husseini K. Manji, M.D., Global Therapeutic Area Head for Neuroscience,
Janssen Research & Development. Janssen Alzheimer Immunotherapy (Janssen AI), a subsidiary of Johnson & Johnson, is a partner with Pfizer in
the Alzheimer's Immunotherapy Program (AIP)
Dr. Manji added, "Janssen remains strongly committed to tackling the enormous unmet medical needs in Alzheimer's disease.
We believe the trial results will provide a rich data set that will advance our understanding of this complex disease and inform future
research in this field. Studies with other compounds in earlier stages of development in the AIP portfolio are continuing and future
development strategies will be discussed jointly by the alliance partners."
“We are obviously very disappointed in the outcomes of this trial. We are also saddened by the lost opportunity to
provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer’s disease and their caregivers,” said Steven J. Romano,
M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.
“Yet these data, and the subgroup and biomarker analyses underway, will further inform our understanding of this complex
disease and advance research in this field.”
About the Bapineuzumab IV Phase 3 Studies
Four placebo-controlled Phase 3 studies comprised the bapineuzumab clinical development program. Janssen AI led the two
completed 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of
patients who are ApoE4 carriers (Study 302) and ApoE4 non-carriers (Study 301).
The two co-primary clinical endpoints are change in the
Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), a validated measure of cognition, and the Disability Assessment for
Dementia (DAD), a validated instrument to measure function.
In addition to the Janssen AI-led studies, Pfizer led two primarily ex-North America 18-month, Phase 3, multicenter,
randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients with mild-to-moderate Alzheimer's
disease who are ApoE4 non-carriers (Study 3000) and carriers (Study 3001).
About the Alzheimer's Immunotherapy Program (AIP)
The Alzheimer's Immunotherapy Program (AIP) of Janssen Alzheimer Immunotherapy and Pfizer Inc. is an equal collaboration
committed to researching and developing selective products for the treatment and/or prevention of neurodegenerative conditions, including
We believe it may be possible to reduce the burden of disease through early intervention in the illness. The AIP is
dedicated to delivering comprehensive and integrated solutions that help address the needs of people impacted by Alzheimer's disease.
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