Alzheimer DiseasePhase 2REVITAA-ALZNCT07756294
Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease
A Phase 2 study testing Empagliflozin and Insulin in people with Alzheimer Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Empagliflozin and Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging
Winston-Salem, North Carolina, 27157
Suzanne Craft, PhD, 336-716-6463, mindadrcahwfb@advocatehealth.org
About this study
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)
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.
Read the detailed description
The proposed pilot study will evaluate the efficacy, safety and tolerability of two therapeutic approaches: treatment with intranasal insulin in combination with anti-amyloid targeting therapy (ATT) and treatment with the sodium-glucose cotransporter type 2 inhibitor empagliflozin in combination with ATT, to correct bioenergetic and vascular dysfunction in adults with mild cognitive impairment due to Alzheimer's disease or mild dementia due to Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- Empagliflozin, Insulin, Insulin Placebo, Empagliflozin Placebo
- Keywords
- mild cognitive impairment, mild dementia, insulin
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
empagliflozin 10 mg every day
InsulinDrug
Intranasal insulin 40 international units four times daily
Insulin PlaceboDrug
matching placebo for intranasal insulin
Empagliflozin PlaceboDrug
matching placebo for empagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Insulin and Empagliflozin Matching Placebo | Experimental | Intranasal insulin 40 international units four times daily and empagliflozin matching placebo as add-on treatment to anti-amyloid therapy Receives: Drug: Insulin; Drug: Empagliflozin Placebo |
| Empagliflozin and Insulin Matching Placebo | Experimental | empagliflozin 10 mg every day and intranasal insulin matching placebo as add-on treatment to anti-amyloid therapy Receives: Drug: Empagliflozin; Drug: Insulin Placebo |
| Double Placebo | Experimental | Placebo for intranasal insulin and placebo for empagliflozin as add-on treatment to anti-amyloid therapy Receives: Drug: Insulin Placebo; Drug: Empagliflozin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related serious adverse events
Number of treatment related serious adverse events experienced by participants during course of study
Measured: Month 6
Secondary outcomes (4)
Alzheimer's Disease Assessment Scale-Cognition Score
The Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-Cog 14) is an evaluation of cognitive impairment in Alzheimer's disease including 14 different sub-tests that can be summed for a total score of 0-90. Higher scores indicate more severe cognitive impairment in Alzheimer's disease.
Measured: baseline and month 6
Modified Preclinical Alzheimer Cognitive Composite 5 Score
The modified Pre-clinical Alzheimer's Cognitive Composite (MPACC5) is a composite of several different cognitive measures designed to assess cognitive functioning in early Alzheimer's disease. Average Z scores will be calculated as baseline and post-intervention Z scores will be calculated using the baseline group mean and standard deviation. Total score range is -3 to 3. Negative z-scores reflect lower than expected cognitive functioning, positive z-scores reflect higher than expected cognitive functioning.
Measured: baseline and month 6
Montreal Cognitive Assessment Score
Montreal Cognitive Assessment (MoCA) is measure of global cognitive functioning used to detect cognitive impairment. It includes several sub-sections assessing various cognitive domains that are summed for a total score of 0-30. Higher scores indicate more intact cognitive functioning, lower scores indicate the presence of cognitive impairment.
Measured: baseline and month 6
Clinical Dementia Rating Scale Score
The Clinical Dementia Rating Scale measures dementia severity based on an interview with the patient and a caregiver. Scores ranging from 0 to 18 with higher scores indicating a higher severity of dementia.
Measured: baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Craft, PhD, Principal investigator, Wake Forest Alzheimer's Disease Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756294
- Sponsor's protocol ID
- IRB00144750
- Acronym
- REVITAA-ALZ
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07756294
- Acronym / sponsor ID
- REVITAA-ALZ / IRB00144750
- Conditions
- Alzheimer Disease
- Keywords
- mild cognitive impairment, mild dementia, insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed pilot study will evaluate the efficacy, safety and tolerability of two therapeutic approaches: treatment with intranasal insulin in combination with anti-amyloid targeting therapy (ATT) and treatment with the sodium-glucose cotransporter type 2 inhibitor empagliflozin in combination with ATT, to correct bioenergetic and vascular dysfunction in adults with mild cognitive impairment due to Alzheimer's disease or mild dementia due to Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin and Empagliflozin Matching Placebo | Experimental | Drug: Insulin, Drug: Empagliflozin PlaceboIntranasal insulin 40 international units four times daily and empagliflozin matching placebo as add-on treatment to anti-amyloid therapy |
| Empagliflozin and Insulin Matching Placebo | Experimental | Drug: Empagliflozin, Drug: Insulin Placeboempagliflozin 10 mg every day and intranasal insulin matching placebo as add-on treatment to anti-amyloid therapy |
| Double Placebo | Experimental | Drug: Insulin Placebo, Drug: Empagliflozin PlaceboPlacebo for intranasal insulin and placebo for empagliflozin as add-on treatment to anti-amyloid therapy |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozinempagliflozin 10 mg every day | Drug | Empagliflozin and Insulin Matching Placebo |
| InsulinIntranasal insulin 40 international units four times daily | Drug | Insulin and Empagliflozin Matching Placebo |
| Insulin Placebomatching placebo for intranasal insulin | Drug | Double Placebo, Empagliflozin and Insulin Matching Placebo |
| Empagliflozin Placebomatching placebo for empagliflozin | Drug | Double Placebo, Insulin and Empagliflozin Matching Placebo |
Primary outcome
Number of treatment-related serious adverse events
Time frame: Month 6
Number of treatment related serious adverse events experienced by participants during course of study
4 secondary outcomes
Alzheimer's Disease Assessment Scale-Cognition Score
Time frame: baseline and month 6
Modified Preclinical Alzheimer Cognitive Composite 5 Score
Time frame: baseline and month 6
Montreal Cognitive Assessment Score
Time frame: baseline and month 6
Clinical Dementia Rating Scale Score
Time frame: baseline and month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Craft, PhD principal investigator
Wake Forest Alzheimer's Disease Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin and Insulin in people with Alzheimer Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Craft, PhD (336-716-6463, mindadrcahwfb@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-related serious adverse events (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.