A Phase 2 interventional study of Empagliflozin and Insulin in Alzheimer Disease, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
Among 16 studies in Alzheimer Disease by Wake Forest University Health Sciences — 3 open to participants now, 4 under way, none of them phase 3. Alzheimer Disease · Wake Forest University Health Sciences.
Among the 16 studies in Alzheimer Disease by Wake Forest University Health Sciences, this one is the 7th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 4 in phase 2, and was the 16th registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
Browse Alzheimer Disease studies →3 of the 16 studies in Alzheimer Disease by Wake Forest University Health Sciences are open now, in 1 country. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Wake Forest University Health Sciences · Sites in United States
By country, each count listing its studies:
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: 55 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 30 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Median enrollment 37 across the 11 interventional studies, 800 across the 5 observational. Of the 9 that completed or were terminated, 5 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
1 of the studies in Alzheimer Disease by Wake Forest University Health Sciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05507905Wake Forest University Health SciencesEffects of Dance and Music Appreciation on Brain Health and Fitness in People at Risk for Alzheimer's Disease | 2027-03-31 |
Among the 16 studies in Alzheimer Disease by Wake Forest University Health Sciences, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intranasal insulin 40 international units four times daily and empagliflozin matching placebo as add-on treatment to anti-amyloid therapy
Drug: Insulin · Drug: Empagliflozin Placebo
empagliflozin 10 mg every day and intranasal insulin matching placebo as add-on treatment to anti-amyloid therapy
Drug: Empagliflozin · Drug: Insulin Placebo
Placebo for intranasal insulin and placebo for empagliflozin as add-on treatment to anti-amyloid therapy
Drug: Insulin Placebo · Drug: Empagliflozin Placebo
empagliflozin 10 mg every day
Intranasal insulin 40 international units four times daily
matching placebo for intranasal insulin
matching placebo for empagliflozin
Number of treatment-related serious adverse events
Number of treatment related serious adverse events experienced by participants during course of study
Time frame: Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and month 6
Change in Alzheimer's disease biomarkers
number of participants with change in Alzheimer's disease biomarkers
Time frame: from baseline to month 6
change in hippocampal volume
change in hippocampal assessed with MRI
Time frame: from baseline to month 6
change in meta-ROI volume
change in meta-ROI volumes assessed with MRI
Time frame: from baseline to month 6
Change in Amyloid-Related Imaging Abnormalities (ARIA)
number of participants with ARIA
Time frame: from baseline to month 6
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 127 non-industry phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 69. This study's planned 17 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Sep 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Empagliflozin · Insulin
Wake Forest University Health Sciences →