Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT02503501|
Recruitment Status : Terminated (Study will not have power to show a difference between groups.)
First Posted : July 21, 2015
Results First Posted : April 9, 2020
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Alzheimer's Disease (AD)||Drug: Insulin glulisine Drug: Placebo||Phase 2|
Disruption of central nervous system (CNS) insulin signaling has been increasingly associated with Alzheimer's Disease pathogenesis, and consequently this disease has been referred to as a type III diabetes of the brain. Clinical trials of intranasal insulin in AD have demonstrated therapeutic effects of intranasal (IN) insulin in memory-impaired adults in terms of memory recall without significantly altering serum insulin or glucose levels. In this study, the investigators are investigating the chronic effects of the rapid acting insulin, glulisine, administered intranasally (IN) 20 IU two times daily in adults with amnestic-mild cognitive impairment (a-MCI) and mild Alzheimer's disease (AD). The investigation will enroll n=90 subjects and follow them over a 6 month period.
This study has the following objectives:
a. To measure the chronic effects of IN insulin glulisine on cognition and function in subjects with aMCI and probable mild AD over a 6 month period.
- To measure the effect of IN insulin glulisine on mood in subjects with aMCI and mild AD over a 6 month period.
- To measure the safety and efficacy of IN glulisine in aMCI and mild AD subjects with non-insulin dependent diabetes over a 6 month period.
- To measure the effect of IN delivery of insulin glulisine on parieto-temporal and posterior cingulate/precuneus glucose metabolism in subjects with aMCI and mild AD over a 6 month period.
- To measure the chronic effect of IN delivery of insulin glulisine on AD-specific cerebrospinal (CSF) biomarkers (Abeta42, tau, and phospho-tau) in subjects with aMCI and mild AD over a 6 month period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Single Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and the Therapeutic Effectiveness of Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease|
|Actual Study Start Date :||September 28, 2015|
|Actual Primary Completion Date :||February 11, 2019|
|Actual Study Completion Date :||February 15, 2019|
Experimental: Insulin Glulisine
Insulin Glulisine 20 IU (0.1ml/10 units in each nostril) per intranasal dose, 2 times per day for 6 months
Drug: Insulin glulisine
Other Name: Apidra
Placebo Comparator: Placebo
Saline 20 IU (0.1 ml in each nostril) per intranasal dose, 2 times per day for 6 months
Bacteriostatic 0.9% Sodium Chloride
Other Name: Saline
- Change in Cognition as Measured by the Alzheimer's Disease Assessment Scale - Cognitive 13 (ADAS-Cog 13) [ Time Frame: Baseline and 6 months ]The ADAS-Cog was developed as an outcome measure for global cognition in clinical trials for Alzheimer's disease. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. The modified ADAS-Cog 13-item scale includes all original ADAS-Cog items with the addition of a number cancellation task and a delayed free recall task, for a total of 85 points (0: no cognitive impairment; 85: severe impairment).
- Change in Functional Performance as Measured by the Clinical Dementia Rating (CDR) Scale [ Time Frame: Baseline and 6 months ]The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. Possible scores on the CDR are 0 (no impairment), 0.5 (very mild), 1 (mild), 2 (moderate), and 3 (severe). The total CDR ratings for each of the six cognitive/functional domains can be added to create a CDR sum of boxes (SOB). The overall SOB score ranges from 0 to 18; with 18 indicating severe impairment and 0 indicating no impairment.
- Change in Functional Performance as Measured by the Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline and 6 months ]The FAQ measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances. The FAQ is a sum of scores ranging from 0 (normal) to 30 (complete dependence on others).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503501
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|HealthPartners Neuroscience Center|
|Saint Paul, Minnesota, United States, 55130|
|Principal Investigator:||Michael H Rosenbloom, MD||HealthPartners Institute|