RecruitMe Clinical Trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamic (PD)Effects of Posiphen in Subjects with Early Alzheimers Disease (AD) DISCOVER
Study of Posiphen in Subjects with Early Alzheimer's Disease (AD) DISCOVER
Sponsor:Alzheimer's Disease Cooperative Study ADCS
Enrolling:Male and Female Patients
Age Range:Between 55 and 85 years old
IRB Number:AAAR6583
U.S. Government ID:NCT02925650
Contact: Evelyn Dominguez: 212-305-2371 / edd5@cumc.columbia.edu
Additional Study Information:

This study is an early phase study of a medication for Alzheimer's Disease, with examination of cerebrospinal fluid. Alzheimer's disease (AD) is a brain disease that results in a loss of mental function. A protein called amyloid or beta-amyloid forms plaques in the brains of people with AD, and scientists believe the build-up of amyloid may play a key role in the developing the disease. The drugs currently approved by the United States Food and Drug Administration (FDA) for AD treat symptoms such as memory loss but do not prevent the disease, delay its onset or slow its progression. This research study will look at an experimental drug called Posiphen. This means it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of AD. This study is for individuals who are 55-85 years old and have been diagnosed with Early AD including Mild Cognitive Impairment due to Alzheimers disease (MCI-AD) or mild Alzheimers disease (AD). Posiphen is being developed as an anti-amyloid drug that may delay the onset or slow the progression of possible AD-related brain damage due to amyloid build-up. The purpose of this study is to: test the safety and tolerability of the study drug. measure the amount of the study drug and drug-related material in the cerebrospinal fluid (CSF, the fluid surrounding the brain and spinal cord) and blood. measure the effect of Posiphen on the levels of certain proteins (biomarkers) associated with AD in the blood and CSF. In this study, participants will be given either active study drug (Posiphen 60 mg taken either once, twice or three times per day) or placebo (capsules that looks like the study drug but do not contain any active drug).

Do You Qualify?
Are you between the ages of 55-85 (inclusive)?YesNo
Do you have Early AD (including Mild Cognitive Impairment due to Alzheimers disease (MCI-AD) or mild Alzheimers disease?YesNo
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Investigator
Lawrence Honig, MD, PhD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Evelyn Dominguez
Email: edd5@cumc.columbia.edu
Phone: 212-305-2371