Who is eligible for clinical trial NCT07756294?

Participants must meet the protocol's inclusion criteria for Alzheimer Disease. The stated age range is 55 Years to 85 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07756294 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-24

Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease (NCT07756294)

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)

🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Wake Forest University Health Sciences

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (16 items).

Location: Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging — Winston-Salem, North Carolina

Age range: 55 Years to 85 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Fluent in English
Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment
Amyloid positive by PET or cerebrospinal fluid criteria
Stable medical condition for 3 months prior to screening visit
Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician)
Stable on Anti-Amyloid Targeting Therapy (lecanemab or donanemab) for at least 8 weeks prior to Baseline Visit
If receiving an acetylcholinesterase inhibitor (donepezil, rivastigmine, galantamine) or memantine or both, must be stable on a dose for at least 30 days prior to Baseline Visit
Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study clinician
Participants must have a study partner who agrees to participate throughout the duration of the study. The study partner must have frequent and sufficient contact (approximately 10 hours per week) with the participant and be able to provide accurate information regarding the participant's cognitive and functional abilities.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
A diagnosis of dementia other than Alzheimer's disease
History of a clinically significant stroke, history of transient ischemic attack within 12 months, or any history of seizures
Current evidence or history in past two years of head injury with loss of consciousness, any major psychiatric disorder including psychosis, unstable major depressive disorder, bipolar disorder
Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
Cancer within the past 2 years with the exception of non-melanoma skin cancers and non-metastatic prostate cancer that has been stable for at least 6 months
Pregnancy or possible pregnancy
Use of anticoagulants
Residence in a skilled nursing facility at screening
Use of an investigational agent within two months of screening visit
Regular use of alcohol, narcotics, anticonvulsants, anti-Parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case-by-case basis by study clinician)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging — Winston-Salem, North Carolina

📞 Contact the Study Coordinator

Phone: (336) 716-6463

Email: mindadrcahwfb@advocatehealth.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Alzheimer Disease clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗