Memory and Insulin in Early Alzheimer's Disease (MAIN)

Jeff Burns, MD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Insulin Aspart; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00581867

10896

Details and patient eligibility

About

To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.

Full description

Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease and cognitively normal older adults. The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Enrollment: 31 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with Early Alzheimer's disease

Exclusion criteria

• Patients with Late Alzheimer's disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Intranasal Insulin Aspart

Experimental group

Description:

Participants were administered intranasal insulin aspart (40 IU) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Treatment:

Drug: Insulin Aspart

Intranasal Saline (placebo)

Active Comparator group

Description:

Participants were administered intranasal saline (placebo) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Treatment:

Drug: Placebo