A Clinical Trial of Exendin-4 for the Treatment of Alzheimer's Disease
- Exendin-4 (or Exenatide) is a medication currently used to treat diabetes, but it has shown promising results in tests of its effectiveness in protecting neurons from damaging processes associated with Alzheimer s disease. It is possible that Exendin-4 may be a suitable treatment for Alzheimer s disease, which involves the gradual deterioration and death of neurons. Researchers are interested in comparing the effects of Exendin-4 with placebo to determine long-term treatment outcomes for individuals with early-stage Alzheimer's disease or mild cognitive impairment.
- To determine the safety and effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage Alzheimer s disease or mild cognitive impairment.
- Individuals at least 65 years of age who have objective evidence of early-stage Alzheimer's disease or mild cognitive impairment in screening testing.
- Participants will be screened with an initial telephone call to evaluate their level of cognitive impairment.
- Following the telephone screening, two in-person screening visits will be required to determine eligibility.
- The first screening visit will involve a medical history and neurological examination, tests of memory and cognition, blood tests, and brain imaging studies. Participants will be required to appoint a Durable Power of Attorney for research and medical care during this protocol.
- The second screening visit will involve blood sugar testing, a lumbar puncture, and collection of blood and saliva samples.
- Eligible participants will be divided into two groups. One group will receive Exendin-4, and the other will receive a placebo. Participants will keep a medication diary and will be scheduled for additional study visits 1, 2, 4 weeks and 3 months after the start of the treatment.
- Participants will have regular followup visits with blood tests, imaging studies, and other examinations 6, 9, 18, 24, and 36 months after the start of the treatment. Another lumbar puncture will be performed at the 18-month followup visit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Clinical Trial of Exendin-4 for the Treatment of Alzheimer's Disease|
- Clinical Dementia Rating (CDR) scale sum-of-boxes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Alzheimer's Disease Assessment scale - cognitive sub-scale (ADAS-cog) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Common Toxicity criteria [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Behavioral and cognitive performance measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Changes on structural and functional MRI and MRS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Hormonal and metabolic changes and changes in cerebrospinal fluid and plasma Alzheimer s disease biomarkers. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Drug: Exendin-4 (Exenatide)
Exendin-4 (or Exenatide) is a medication currently used in the treatment of diabetes mellitus (DM). Exendin-4 has generated promising results as an agent protecting neurons from a number of assaults both in the laboratory and in studies on animals. Specifically, there is pre-clinical evidence that Exendin-4 may be a treatment for Alzheimer s disease (AD). Based on these facts, we propose a double blind randomized placebo-controlled clinical trial to assess the safety and efficacy of Exendin-4 treatment in participants with early Alzheimer s disease (AD). Our main hypothesis is that long-term administration of Exendin-4 in participants with early AD or mild cognitive impairment (MCI) is safe and will slow the progression of AD. 115 participants will be enrolled into treatment on the basis of symptoms and signs characteristic of early AD and Cerebrospinal Fluid (CSF) biomarker results, out of approximately 230 potential participants who will go through screening. Then, enrolled participants will be randomly assigned into one of two groups (Exendin-4 vs. Placebo) and will be followed at regular intervals for three years. The efficacy of Exendin-4 will be primarily assessed in terms of cognitive measures of disease progression and secondarily in terms of behavioral measures, changes on brain MRI and biomarkers. All research will be performed on the National Institute on Aging (NIA) Clinical Research Unit located on the 5th floor of Harbor Hospital.
|Contact: Dimitrios I Kapogiannis, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institute on Aging, Clinical Research Unit||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Dimitrios I Kapogiannis, M.D.||National Institute on Aging (NIA)|