Discover is an early stage clinical trial designed to quickly test whether the study drug in Alzheimer’s disease (AD) hit their targets and work as scientists intended. The Discover Study is a randomized, double-blind, placebo controlled study. “Randomized” means that it will be determined by chance which of the treatment groups you will be assigned. “Double-blind” means that neither the participant nor the research team will know whether a participant is taking the placebo or the study drug. Participants will be treated with a low, middle, or high dose of Posiphen, or a placebo (a capsule that looks like the study drug but does not contain active ingredients).
In the Discover trial, scientists will be testing the study drug Posiphen, which may delay AD onset or slow the progression of AD- related brain damage by targeting the build-up of amyloid plaques. Discover is a Phase 1b study. It means that participants will help to determine the side effects of the drug and how the drug is broken down by the human body (pharmacokinetics). The primary outcome measures of this study are safety and tolerability, pharmacokinetics measured on serum and cerebrospinal fluid, and the dose effect on the production rate of Beta Amyloid 40 which is commonly found in AD patients.
Posiphen is a small, orally active, study drug that specifically inhibits the synthesis of amyloid precursor protein (APP), Tau and α-Synuclein. It is distinct from other Alzheimer’s disease drugs currently in development, because it inhibits the formation of several toxic proteins, rather than removing individual toxic protein after they are produced. It was discovered by the US National Institute on Aging (NIA) and has the potential to stop, delay or slow the progression Alzheimer’s disease.
We are looking for:
- Participants within the ages of 55-89
- In good health
- No frailty
- Profile consistent with early Alzheimer’s disease, including Mild Cognitive Impairment or mild AD
- A “study partner” to accompany them to some study visits, answer questions specific to that participant, ensure they are taking the study drug as instructed and will communicate any health changes over the duration of the study
The participant will undergo an MRI and be willing to undergo a lumbar puncture at the beginning of the study and to have another lumbar puncture to put a catheter in the Cerebral Spinal Fluid Space, which will allow CSF to be easily sampled during the 36-hour period when subjects are confined in the hospital.
The Discover Study is actively recruiting at the following academic medical centers! If you are interested in learning more about the study, please contact Archana Balasubramanian by email at email@example.com.