RAGE Inhibitor Study
Enrollment — Closed
A double-blind, placebo-controlled, randomized, multicenter study evaluating the efficacy and safety of eighteen months of treatment with PF-04494700 (TTP488) in participants with mild-to-moderate Alzheimer's disease
Where is this study being conducted?
Baylor College of Medicine is one of about 40 sites participating in this trial, which will enroll approximately 399 subjects across the U.S.
What is the purpose of this study?
The purpose of this study is to assess the effectiveness and safety of a new drug (PF-04494700) in mild to moderate Alzheimer's disease patients. PF-04494700 blocks the receptor for advanced glycation end products. RAGE may play a role in the build-up of beta amyloid in the brain. Beta amyloid is found in plaques in the brains of people with AD. It may be involved in producing inflammation in the brain, which may play a role in AD. This new drug that is not available outside this study.
Who is the sponsor?
This study is being sponsored by Pfizer and the Alzheimer's Disease Cooperative Study (NIH).
Who is eligible to participate?
A person may be eligible to participate if he or she:
- Is a male or female aged between aged 50 or older. Female subjects must be surgically sterile or postmenopausal for two years
- Has a diagnosis of Alzheimer's disease, with a score of 14-26 on the Mini-Mental Status Exam
- Has contact with a reliable caregiver (at least three days a week) who can accompany them to study visits
- Speaks English fluently and is in generally good physical health.
What is involved for individuals who wish to participate?
At an initial screening visit, study staff will review the participant's medical history and perform a physical and neurologic examination and brief memory assessment. Then, if the subject meets study criteria, study staff will collect blood and urine samples for lab tests, do an EKG, and refer subjects for a chest x-ray and brain CT or MRI, if needed. If accepted into the study, study staff will ask the subject to return to the clinic for 11 more study visits over a 21-month period (22 months total).
What is the study design?
This is a Phase II randomized, double-blind, placebo-controlled study. Participants will be randomly assigned (by chance) to one of three groups: One of two different doses of PF-04494700, or placebo (inactive substance or "sugar pill"). Subjects will have a 2 in 3 chance of receiving PF-04494700. Neither the participants nor the research team will know to which group each subject has been assigned ("double-blind"). Subjects will receive active drug or placebo capsules, to be taken in the morning for 18 months
Can participants in this study continue taking their regular medications?
Patients must have been taking a stable dose of an acetylcholinesterase inhibitor (Aricept, Razadyne, or Exelon) for at least four months to be in the study. Patients may be taking Namenda, but should have been taking it for four months prior to enrollment. Subjects will continue to take their regular Alzheimer's medication throughout the study. Other behavioral medications must have been at a stable dose for at least four weeks prior to study enrollment. There are some other 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 can I get more information?
Contact: Tracy Dawson at Baylor College of Medicine