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NCT01767909 · ClinicalTrials.gov registry record · Phase 2
The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)
A Phase 2 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT01767909 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 240 participants.
The verdict
NCT01767909, a Phase 2 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median population age increases. Current FDA-approved therapies are modestly effective at best. This study will examine a novel therapeutic approach using intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful, information gained from the study has the potential to move INI forward rapidly as a therapy for AD. The study will also provide evidence for the mechanisms through which INI may produce benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal atrophy. These results will have considerable clinical and scientific significance, and provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology. Growing evidence has shown that insulin carries out multiple functions in the brain, and that insulin dysregulation may contribute to AD pathogenesis. This study will examine the effects of intranasally-administered insulin on cognition, entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months of treatment with INI compared to placebo, subjects will improve performance on a global measure of cognition, on a memory composite and on daily function. In addition to the examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4) allele carriage predict treatment response. In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months, following an open-label period of 6 months where all participants will be given active drug. The
Interventions
- DRUG Placebo
- DRUG Insulin (Humulin® R U-100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2014-01-08 |
| Est. Completion | 2018-12-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01767909
The ClinicalTrials.gov registry entry for NCT01767909 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01767909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01767909 about?
NCT01767909 is a clinical study titled "The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)". An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median populatio...
What is the current status of trial NCT01767909?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2014-01-08. Estimated completion is 2018-12-11.
What interventions are being tested in trial NCT01767909?
The interventions under investigation include: Placebo (DRUG), Insulin (Humulin® R U-100) (DRUG).
Who is sponsoring clinical trial NCT01767909?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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