CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Saline +2 moredrug
Likely dose
Insulin detemir 20IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01595646
NCT01595646Phase 2Completed

Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)

Wake Forest University Health Sciences·interventional·Posted May 10, 2012·Updated Nov 17, 2020

In Brief

A Phase 2 clinical trial evaluating Saline, Insulin detemir, and 1 other intervention for Alzheimer's Disease and Mild Cognitive Impairment. Completed, enrolled 37 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2012
Enrollment StartNov 1, 2011
Primary CompletionMar 12, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.1 years ago

Interventions

Salinedrug

Saline, administered intranasally twice per day for a 16 week duration

Insulin detemirdrug

20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)

Insulindrug

20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)