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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: Clinical Trial Phase 2 study, sponsored by National Institute on Aging (NIA).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Tolerability of exenatide (nausea is the most common expected adverse event of exenatide)
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 |
Why NCT01255163 stopped before completion
NCT01255163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo SC is the first listed.
NCT01255163 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01255163's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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