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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07756294
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    empagliflozin 10 mg every day
  • Insulin — DRUG
    Intranasal insulin 40 international units four times daily
  • Insulin Placebo — DRUG
    matching placebo for intranasal insulin
  • Empagliflozin Placebo — DRUG
    matching placebo for empagliflozin

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 31, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin and Empagliflozin Matching Placebo
    Intranasal insulin 40 international units four times daily and empagliflozin matching placebo as add-on treatment to anti-amyloid therapy
  • Experimental: Empagliflozin and Insulin Matching Placebo
    empagliflozin 10 mg every day and intranasal insulin matching placebo as add-on treatment to anti-amyloid therapy
  • Experimental: Double Placebo
    Placebo for intranasal insulin and placebo for empagliflozin as add-on treatment to anti-amyloid therapy

Primary Outcome Measure

Number of treatment-related serious adverse events [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy AgingWinston-SalemNorth Carolina27157
Suzanne Craft, PhD
[email protected]
336-716-6463

Find similar trials in Winston-Salem, NC

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By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging· Winston-Salem, NC

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