REVITAA-ALZ

Not yet recruitingPhase 2

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

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)

Lead sponsor

Wake Forest University Health Sciences

Assets

Empagliflozin / Insulin

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•Amyloid biomarker required (PET/CSF)•Study partner/caregiver required•MRI contraindications excluded•Brain MRI excludes superficial siderosis, vasogenic edema

Primary endpoint

•Number of treatment-related serious adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIRB00144750

NCT IDNCT07756294

Timeline

Milestones

Study first posted2026-08-10actual

Last update posted2026-09-30actual

Study start2026-11estimated (month precision)

Primary completion2028-04estimated (month precision)

Study completion2028-04estimated (month precision)

Assets

Drug assets

Empagliflozin Insulin

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

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)

•Any history of immunologic disease (e.g. lupus, rheumatoid arthritis, Crohn's disease) or systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives

•History of a bleeding disorder that is not under adequate control, including a platelet count less than 50,000 or INR greater than 1.5

•Contraindications for MRI, including claustrophobia or the presence of contraindicated metal implants/cardiac pacemaker

•Baseline MRI Findings: More than four microhemorrhages defined as 10mm or less at the greatest diameter; A single macro hemorrhage greater than 10mm at greatest diameter; An area of superficial siderosis; Evidence of vasogenic edema; More than two lacunar infarcts or stroke involving a major vascular territory; Severe subcortical hyperintensities consistent with Fazekas score of 3; Evidence of amyloid beta-related angiitis (ABRA); Cerebral amyloid angiopathy (CAA); Cerebral contusion, encephalomalacia, brain aneurysm or other vascular malformations, central nervous system infection, brain tumor, or other major intracranial pathology that may cause cognitive impairment

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Neuroimaging

Amyloid biomarkers

Safety / tolerability / PK

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognition Score

Time frame:baseline and month 6

ADAS-Cog

descriptive

Secondary/protocol endpoint

Modified Preclinical Alzheimer Cognitive Composite 5 Score

Time frame:baseline and month 6

descriptive

Secondary/protocol endpoint

Montreal Cognitive Assessment Score

Time frame:baseline and month 6

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating Scale Score

Time frame:baseline and month 6

descriptive

Amyloid biomarkers

1 endpoint

Other/protocol endpoint

Change in Amyloid-Related Imaging Abnormalities (ARIA)

Time frame:from baseline to month 6

change from baseline, improvement

Neuroimaging

2 endpoints

Other/protocol endpoint

change in hippocampal volume

Time frame:from baseline to month 6

change from baseline, improvement

Other/protocol endpoint

change in meta-ROI volume

Time frame:from baseline to month 6

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of treatment-related serious adverse events

Time frame:Month 6

event count, event

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Change in Alzheimer's disease biomarkers

Time frame:from baseline to month 6

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.