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NOT YET RECRUITING
NCT07756294
PHASE2

Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.

Official title: REstoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in ALZheimer'ss Disease (REVITAA-ALZ): A Placebo-controlled Trial of Intranasal Insulin vs. Empagliflozin in Mild Cognitive Impairment (MCI) or Early Alzheimer's Disease (AD) Treated With Anti-Amyloid Targeting Therapy (Lecanemab or Donanemab)

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2028-04

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Empagliflozin

empagliflozin 10 mg every day

DRUG

Insulin

Intranasal insulin 40 international units four times daily

DRUG

Insulin Placebo

matching placebo for intranasal insulin

DRUG

Empagliflozin Placebo

matching placebo for empagliflozin

Locations (1)

Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging

Winston-Salem, North Carolina, United States