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NCT01617577 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety of Filgrastim in Alzheimer's Disease
A Phase 1 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01617577 is a Phase 1 study that has completed, run by University of South Florida. The registered enrollment target is 8 participants.
The verdict
NCT01617577, a Phase 1 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Filgrastim (G-CSF) is widely used for treatment of patients who have a deficiency of white blood cells. It is also routinely used to stimulate and mobilize stem/progenitor cells for bone marrow transplantation. In studies of thousands of healthy donor subjects treated with G-CSF, the side-effects profile has been reported to be mild and reversible. Currently, G-CSF is under investigation in clinical trials in Germany and the US that aim to enhance recovery from strokes and heart attacks. In animal studies, G-CSF has been observed to improve cognitive performance and to markedly reduce amyloid deposition in hippocampus and entorhinal cortex in a mouse model of Alzheimer's Disease (AD). Since this drug is being used safely in many people throughout the world, the investigators hypothesize that it will also be safe to give to patients with Alzheimer's disease and that it may improve some aspects of memory and thinking. The present pilot study has two goals or objectives: 1) to investigate the effects of a five day schedule of Filgrastim administration on cognitive function and 2) to assess its tolerability and safety in a small group (12 patients) with mild to moderate stage AD. Patients who are eligible for the study will be randomly assigned to one of two groups (n=6 per group). One group will receive a five-day course of Filgrastim injections and the other group of subjects will receive vehicle injections (solution without drug). At the end of the first phase of the study (week 8), the groups will cross over to receive either vehicle or Filgrastim as appropriate. In this way all subjects will have received the active medication by the end of the study. After the study is finished the investigators should know whether or not Filgrastim improves some aspects of thinking and memory. And the investigators should know whether or not it is safe to give this medication to patients with Alzheimer's disease. To ensure that the drug is safe, a Safety Monitoring Committee will
Interventions
- DRUG Placebo
- DRUG G-CSF; filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01617577
The ClinicalTrials.gov registry entry for NCT01617577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01617577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01617577 about?
NCT01617577 is a clinical study titled "Efficacy and Safety of Filgrastim in Alzheimer's Disease". Filgrastim (G-CSF) is widely used for treatment of patients who have a deficiency of white blood cells. It is also routinely used to stimulate and mobilize stem/progenitor cells for bone marrow transplantation. In studies of thousands of healthy donor subjects treated with G-CSF, the side-effects pr...
What is the current status of trial NCT01617577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2009-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01617577?
The interventions under investigation include: Placebo (DRUG), G-CSF; filgrastim (DRUG).
Who is sponsoring clinical trial NCT01617577?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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