ST101 in Alzheimer's Disease Study
Enrollment — Closed
IRB Number: H-24384
What is the purpose of this study?
The purpose of this study is to assess the effectiveness and safety of a new drug (ST101) compared to placebo in moderate to moderately severe Alzheimer's disease (AD) patients who are already taking donepezil. AD pathology causes multiple neurotransmitter deficits in the brain and ST101 works by increasing the levels of two important neurotransmitters, acetylcholine and dopamine. This new drug works differently than medications currently available to enhance levels of neurotransmitters.
Who sponsors this clinical trial?
This is a Phase II randomized, double-blind, placebo-controlled study is being sponsored by Sonexa Therapeutics, Inc.
What is the design of this study?
Participants will be randomly assigned (by chance) to one of four groups: One of three different doses of ST101 (10 mg, 60 mg, and 120 mg) or placebo (inactive substance or "sugar pill"). Subjects will have a 3 in 4 chance of receiving ST101. Neither the participants nor the research team will know which group a participant has been assigned ("double-blind"). Subjects will receive active drug or placebo capsules, to be taken in the morning for 12 weeks along with a 10 mg tablet of Aricept.
What is involved for individuals who wish to participate?
At an initial screening visit, study staff will review the medical history and perform a physical and neurologic examination. Then, if the subject meets study criteria, study staff will collect blood and urine samples for lab tests, do an EKG, and perform neurobehavioral tests. If a CT Scan or MRI has not been conducted within the past 18 months this will be ordered. Within 30 days after the Screening visit the participant will return and enter a 30-day pre-randomization period and a 30-day supply of Aricept will be given to the caregiver. Treatment will begin after pre-randomization if a subject's compliance with taking donepezil is greater than 80%. Study drug will be given at the first treatment visit and there will be follow-up clinic visits at week 4, week 8, week 12, and week 16 after beginning treatment (seven clinic visits during the trial).
Who is eligible to participate?
A person may be eligible to participate if he or she:
- Is a healthy male or female aged 50 or older
- Has a diagnosis of Alzheimer's disease, with a score of 10-20 on the Mini-Mental Status Exam (MMSE) and takes Aricept 10 mg daily
- Has contact with a reliable caregiver (daily) who can participate in all clinic visits and some study procedures
- Speaks English fluently and is in generally good physical health.
Can participants in this study continue taking their regular medications?
Patients may not use any prescription AD treatment other than Aricept or any other investigational medication for at least 60 days before screening. Excluded drugs include medications that would impair the evaluation of AD symptoms. There is a list of allowable drugs that may be used during the study that include medication used to control acceptable chronic medical conditions or drugs used on an as needed basis. There are medications (prescription and non-prescription) that are not allowed in this study. The study doctor will let you know which medications are not allowed in this study.
Are there any risks associated with this study?
This study drug is an investigational drug and all of the possible side effects are not fully known. Experience with the study drug in humans is limited, but has been generally well tolerated in clinical trials to date.
Where is this study being held?
Baylor College of Medicine is one of about 25 sites participating in this trial, which will enroll approximately 200 subjects in North America.
For more information
Contact: Lindsay Reid at Baylor College of Medicine