SNIFF - Combo INI+EMPA Trial

• Status: Recruiting
• Trial end date: 2028-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed pilot study will provide safety and efficacy preliminary data regarding singular and combined effects of two therapeutic approaches, intranasal insulin and treatment with the sodium-glucose cotransporter type 2 inhibitor (SGLT2i) empagliflozin, to correct bioenergetic and vascular dysfunction in adults with preclinical Alzheimer's disease (AD) and amnestic mild cognitive impairment (aMCI) or early AD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Empagliflozin; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Age 55 to 85 (inclusive)

2. Fluent in English

3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)

4. Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria

5. Stable medical condition for 3 months prior to screening visit

6. Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)

7. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion Criteria:

1. A diagnosis of dementia other than Alzheimer's disease (AD)

2. History of a clinically significant stroke

3. Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder

4. Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus

5. Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit

6. History of seizure within past five years

7. Pregnancy or possible pregnancy

8. Use of anticoagulants

9. Residence in a skilled nursing facility at screening

10. Use of an investigational agent within two months of screening visit

11. 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 the study physician)