Exendin-4 for the Treatment of Alzheimer's Disease
Exendin-4 for the Treatment of Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This study is designed 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.
Patient Qualifications:
| Min Age | Gender | Healthy Volunteers |
|---|---|---|
65 Years | Both | No |
Inclusion Criteria:
- Clinical Dementia Rating (global CDR) of 0.5 or 1; memory box score of at least 0.5; Mini Mental Status Exam (MMSE) score of >20
- Isolated or predominant episodic memory deficit
- Hamilton Depression Scale score of less than or equal to 12
- An informant or caregiver who has frequent contact with the participant (e.g., an average of 10 hours per week or more) must be available to provide history, accompany the participant to all clinic visits, and sign informed consent
- Willing to have an initial lumbar puncture and provide cerebrospinal fluid at specified time points
Exclusion Criteria:
- Additional neurological or psychiatric disease
- History of significant head trauma
- History of stroke, depression, or substance abuse
- Diabetes
- Current or previous treatment with Exendin-4
Detailed Description:
Exendin-4 (or Exenatide) is a medication currently used to treat diabetes mellitus. 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 preclinical evidence that Exendin-4 may be a treatment for Alzheimer's disease. This double blind, randomized, placebo-controlled clinical trial will assess the safety and efficacy of Exendin-4 treatment in participants with early-stage Alzheimer's.
The main hypothesis is that long-term administration of Exendin-4 in participants with early Alzheimer's or mild cognitive impairment (MCI) is safe and will slow the progression of Alzheimer's. A total of 115 participants will be enrolled into treatment on the basis of symptoms and signs characteristic of early Alzheimer's. They will be randomly assigned into one of two groups (Exendin-4 or placebo) and will be followed at regular intervals for 3 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.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.2713976, -76.5603828 | National Institute on Aging Clinical Research Unit | Baltimore | Maryland | 21224 | Recruiting | Name: Dimitrios I Kapogiannis, MD Phone: 301-451-9286 kapogiannisd@mail.nih.gov |
Lead Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Dimitrios I. Kapogiannis, MD | Principal Investigator | National Institute on Aging (NIA) |
Study Contact:
| Name | Phone | |
|---|---|---|
Dimitrios I. Kapogiannis, MD | 301-451-9286 |
Locations
ClinicalTrials.gov ID
NCT01255163 (follow link to view full record on ct.gov in new window)
Official Title:
A Clinical Trial of Exendin-4 for the Treatment of Alzheimer's Disease
Study Start Date:
November 2010
Study End Date:
December 2015
Disease Stage:
Early
Enrollment:
230
Trial References:
