AL-108 Trial (Phase IIa) Shows Promise of Tau-Targeted Therapies in MCI
MCI can be divided into two broad subtypes. Amnestic MCI (aMCI) significantly affects memory, while nonamnestic MCI does not. Other functions, such as language and attention span, may be impaired in either subtype. Persons with aMCI convert to Alzheimer's at a much higher rate than the normal aging population.
Donald Schmechel, MD, Adjunct Professor of Medicine (Geriatrics), Professor of Psychiatry, and Associate Professor of Neurobiology of Duke University Medical Center, Durham, NC, and colleagues conducted a Phase IIa clinical trial of AL-108 (Allon Therapeutics), an experimental therapy designed to combat neurofibrillary tangles (NFT). NFT are one of the early key abnormal brain changes in aMCI and Alzheimer's. AL-108 is a nasal spray formulation of an eight amino acid peptide, known as NAPVSIPQ, derived from the neuroprotective protein Activity-Dependent Neuroprotective Protein.
The trial was a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability and effect of two doses of AL-108 after 12 weeks of treatment (low dose=5 mg daily, high dose=15 mg twice daily). The study was open to men and women, age 55-85 years (inclusive, mean age=69.4) with Mini-Mental State Exam scores =24, self-reported memory complaint corroborated by spouse or companion, and Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score =5. One hundred forty-four (144) subjects were randomized at 16 centers in the U.S. Cognitive tests were conducted four weeks prior to drug administration, and then at baseline, four, eight, 12, and 16 weeks.
The primary endpoint is a change from baseline at Week 12 in a
composite score that focuses on measures of memory. Secondary efficacy
endpoints include analysis of the change in
|SOURCE Alzheimer's Association|
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