Galindo-Mendez 2020 / NCT02415556

Study ID(s) and Acronym(s)
NCT02415556 / MemAID
Current Status of Trial
Ongoing
Study Aim
Primary Prevention
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Insulin // Placebo
Dosage and Duration
a prospective, two-center, randomized, double-blind, placebo-controlled trial of 210 subjects (120 T2DM and 90 non-diabetic older adults) randomized into four treatment arms (60 T2DM-INI, 60 T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo) evaluating the long-term effects of daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline) over 24 weeks and 24 weeks of post-treatment follow-up.
Absolute Number of Participants
210
Health Status/Diagnosis
Type 2 Diabetes (T2DM)
Primary outcomes
1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety.