A Pilot Clinical Trial of Exendin-4 in Alzheimer's Disease
Status:
Terminated
Trial end date:
2016-11-18
Target enrollment:
Participant gender:
Summary
Background:
Exendin-4 (or Exenatide) is a medication currently used to treat diabetes that has shown
promising results in animal and cellular models of Alzheimer's disease. It is possible that
Exendin-4 may be a treatment for Alzheimer's disease, which involves the gradual
deterioration and death of neurons. Researchers are interested in studying the safety and
comparing the effects of Exendin-4 with placebo on cognitive performance, clinical
progression of dementia, various chemicals measured in blood and cerebrospinal fluid, and
brain MRI, in individuals with early-stage Alzheimer's disease or mild cognitive impairment.
Objectives:
To determine the safety and tolerability of twice daily administration of Exendin-4, as well
as to acquire preliminary evidence for effects on cognitive performance, clinical progression
of dementia, various chemicals measured in blood and cerebrospinal fluid, and brain MRI, in
individuals with early-stage Alzheimer's disease or mild cognitive impairment.
Eligibility:
Individuals at least 60 years of age who have objective evidence of early-stage Alzheimer's
disease or mild cognitive impairment in screening testing.
Design:
- Participants will be screened.
- Following the telephone screening, two in-person screening visits to determine
eligibility.
- The screening visit will involve a medical history and neurological examination, tests
of memory and cognition, a lumbar puncture, collection of blood and saliva samples, and
brain Magnetic Resonance Imagine (MRI) studies. Participants will be required to appoint
a Durable Power of Attorney for research and medical care during this protocol.
- Eligible participants will be divided into two groups (double-blind randomization). One
group will receive Exendin-4 SC twice daily, and the other will receive a placebo.
Participants will keep a medication diary and will be scheduled for additional study
visits 1 and 2 weeks after the start of the treatment.
- Participants will have regular followup visits with blood tests, cognitive tests,
imaging studies, and other examinations 6, 12, and 18 months after the start of the
treatment. Another lumbar puncture may be performed optionally at the 18-month followup
visit.