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Making Progress Towards the Treatment and Prevention of Alzheimer’s Disease
Alzheimer's Research Center

Clinical Trials

Go To CLINICALTRIALS.GOV for trials in your area. Highlights from drugs in development include:

AL-108 and AL-208, two proteins found naturally in the brain, are being investigated by Allon Therapeutics Inc. for the treatment of Alzheimer’s. The results of a 12-week human intranasal trial of AL-108 were promising, showing a significant improvement in short-term recall and working memory in Alzheimer’s patients. AL-208, also administered intranasally, showed promise, as it was able to significantly penetrate the blood brain barrier in Alzheimer’s patients. Both therapeutics are slated for additional clinical trials beginning at the end of 2008.

Dimebon, a medication for the treatment of mild to moderate Alzheimer’s is currently screening patients for Phase III clinical trials. The small molecule medication, marketed by Medivation, has been used in Russia for over 20 years as an anti-histamine. Alzheimer’s patients receiving Dimebon for 12 months in the Phase II trial experienced improved cognition, memory, activities of daily living and behavior. Additionally, the patients who extended their treatment for 18 months had preservation of function close to their starting baselines.

Intravenous Immunoglobulin (IVIg), is a medication composed of a mixture of antibodies derived from human blood currently being used to treat people with primary immunodeficiency disorders. It is now being investigated as a potential anti-amyloid therapy for Alzheimer’s disease. Results from an 18 month IVIg Phase II clinical trial showed significant and clinically relevant improvements in cognitive and global clinical measures. A large-scale, 18-month, Phase III clinical trial of IVIg is now underway to test for long-term IVIg benefits.

LY2062430, a monoclonal antibody, was used in a 12-week human Phase II trial, which showed binding of the antibody to beta amyloid in the brain, increasing the rate of its removal from the body. However, the antibody did not change cognitive scores or the total amount of amyloid plaque within the body as a whole. In light of these results, it was suggested that the plaques do begin to dissolve after 12 weeks of treatment and move from the brain to the blood, but more treatment time is required for measurable cognitive improvements. The researchers at Eli Lilly and Company have planned a Phase III clinical trial of this drug for 2009.

Methylthionium chloride (MTC, rember TM), is a new drug aimed at alleviating the cognitive and behavioral deficits in Alzheimer’s patients due to the buildup of brain lesions known as neurofibrillary tangles. Researchers at TauRx have shown that remberTM dissolves these tangles, blocks their toxic effects, and has cognitive and behavioral benefits in both human and animal models. In fact, the greatest effect of the drug was seen in the brain regions most severely affected in Alzheimer’s disease. The researchers now aim to confirm these findings in a larger Phase III trial.

PBT2, a compound developed by Prana Biotechnology, has been shown to reduce the harmful interaction of beta amyloid protein, the main component of plaques, with metals and restore normal functioning to brain cells. A promising Phase IIa trial was recently completed using the drug, which led to a reduction in amyloid beta proteins as well as some cognitive improvements in patients with early Alzheimer’s disease. A larger scale trial is being planned for the drug.

SouvenaidTM, a once-a-day medical drink consisting of a combination of naturally occurring nutrients, was designed to enhance brain cell outgrowth, synapse formation, and neurotransmitter release in an effort to improve cognitive function. The drink, developed by researchers at MIT and sponsored by Danone Research, was found to improve some forms of cognition in patients with mild Alzheimer’s, who took the drink over a 12-week period. An advanced clinical trial is planned.