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NCT01255163 · ClinicalTrials.gov registry record · Phase 2
A Pilot Clinical Trial of Exendin-4 in Alzheimer's Disease
A Phase 2 study, sponsored by National Institute on Aging (NIA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01255163 is a Phase 2 study that was terminated before completion, run by National Institute on Aging (NIA). The registered enrollment target is 57 participants.
The verdict
NCT01255163, a Phase 2 study, was terminated before completion, sponsored by National Institute on Aging (NIA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study 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 fo
Interventions
- DRUG Placebo SC
- DRUG Exendin-4 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-11-21 |
| Est. Completion | 2016-11-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01255163
The ClinicalTrials.gov registry entry for NCT01255163 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo SC is the first listed.
NCT01255163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01255163 about?
NCT01255163 is a clinical study titled "A Pilot Clinical Trial of Exendin-4 in Alzheimer's Disease". 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 o...
What is the current status of trial NCT01255163?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2010-11-21. Estimated completion is 2016-11-18.
What interventions are being tested in trial NCT01255163?
The interventions under investigation include: Placebo SC (DRUG), Exendin-4 SC (DRUG).
Who is sponsoring clinical trial NCT01255163?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
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