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NCT01595646 · ClinicalTrials.gov registry record · Phase 2
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)
A Phase 2 study of Mild Cognitive Impairment and Alzheimers Disease, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT01595646 is a Phase 2 study of Mild Cognitive Impairment and Alzheimers Disease that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 37 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01595646, a Phase 2 study of Mild Cognitive Impairment and Alzheimers Disease, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI). The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain functions, and that insulin dysregulation can contribute to AD pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have beneficial effects on brain function. Intranasal administration of insulin increases insulin signaling in the brain without raising peripheral levels and causing hypoglycemia. Insulin detemir is an insulin analogue that may have better action in brain than other insulin formulations because of its albumin binding properties. The investigators will test the therapeutic effects of intranasally-administered insulin detemir in a study in which participants will receive insulin detemir, regular insulin, or placebo over a four month period. The investigators will test the hypothesis that insulin and insulin detemir will both improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that insulin detemir will have the greatest effect.
Conditions Studied
Interventions
- DRUG Saline
- DRUG Insulin
- DRUG Insulin detemir
Study Locations (2)
North Carolina
- Wake Forest Baptist Hospital - Winston-Salem
Washington
- VA Puget Sound Health Care System - American Lake Division - Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-03-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01595646
The ClinicalTrials.gov registry entry for NCT01595646 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (97% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 3 interventions - of which Saline is the first listed.
NCT01595646 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Washington.
Frequently Asked Questions
What is clinical trial NCT01595646 about?
NCT01595646 is a clinical study titled "Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)". The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI). The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain ...
What is the current status of trial NCT01595646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2011-11. Estimated completion is 2015-03-12.
What conditions does trial NCT01595646 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Alzheimers Disease.
What interventions are being tested in trial NCT01595646?
The interventions under investigation include: Saline (DRUG), Insulin (DRUG), Insulin detemir (DRUG).
Who is sponsoring clinical trial NCT01595646?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01595646 being conducted?
This trial has 2 study locations across North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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