Alzheimer's Advances Depend on Early Diagnosis

April 1, 2011

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2011, Volume 20, Issue 4

Updates on Alzheimer's disease.

According to PhRMA's "Medicines in Development for Alzheimer's Disease" report issued in 2010, there are currently five marketed drugs that temporarily reduce symptoms of Alzheimer's. However, there are no vaccines to prevent the disease or medications that will delay its onset, severity, or cure the disease. At the core of the disease is early diagnosis. It is important that Alzheimer's be detected in the predementia stage. Currently, when Alzheimer's is detected, brain atrophy has already begun and the prognosis is about nine years to death. In addition to the benefits on quality-of-life, PhRMA notes that a treatment to delay onset by five years would save the healthcare system $447 billion.

Below are some highlights about current medicines in development.

In the vaccine area, AFFiRiS's currently has three Alzheimer's vaccine candidates that are designed to induce antibodies targeting the beta-amyloid peptide that is believed to contribute to the pathology of Alzheimer's. With Affitope AD03, the third of its candidates, which is in Phase I, AFFiRiS additionally targets modified beta-amyloid peptides which are presumed to have different toxicity profiles in humans. Its clinicaltrials.gov identifier is NCT01309763. Affitope AD02 is currently in Phase II to study safety and tolerability of different doses for early Alzheimer's. Its clinicaltrials.gov identifier is NCT01117818.

In the area of disease diagnosis, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended against approval of Eli Lilly's Amyvid (florbetapir) in mid-January based on the currently available data; but, voted unanimously to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans. The FDA did take the committee's advice and issued Lilly a complete response letter addressing the reader issue in March.

Amyvid is a molecular imaging agent that is injected into the patient who then undergoes a PET scan to detect beta-amyloid plaque in the brain, which would be an indicator of Alzheimer's disease. At issue is the ability to ensure the readers of the scans are trained adequately for the needs of market implementation.

Lilly acquired Avid Radiopharmaceuticals for $300 million in December 2010. Amyvid was the first beta-amyloid imaging compound to enter multi-center, investigational new drug clinical studies in the United States. Prior to receiving the complete response letter, Eli Lilly CEO John Lechleiter said in interviews that the company was confident it would work with the FDA and get approval.

In the area of genetics, the Alzheimer's Association announced in February, the launch of a collaboration of the International Genomics of Alzheimer's Project, to discover and map the genes that contribute to Alzheimer's disease. The collaboration includes universities in Europe and the United States. In the initial phase of the work, more than 20,000 people with Alzheimer's and about 20,000 healthy elderly subjects will be compared. As the study progresses, 10,000 additional people with Alzheimer's and the same number of healthy elderly subjects will be added to the study. The subjects for these studies come from different Alzheimer research project locations across Europe, the United Kingdom, the United States, and Canada.

Ceregene is developing a gene therapy product in Phase II trials, however, its candidate for Parkinson's is currently garnering more attention.

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