SNIFF - Combo INI+EMPA Trial

Last updated: December 19, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

2

Condition

Memory Problems

Dementia

Memory Loss

Treatment

Placebo (Insulin Diluent)

Placebo (Capsules)

Aptar Pharma CPS Intranasal Delivery Device

Clinical Study ID

NCT05081219
IRB00075245
  • Ages 55-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 55 to 85 (inclusive)

  2. Fluent in English

  3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mildAlzheimer'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 (exceptionsmay 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 bejudged to be clinically insignificant by the study physician

Exclusion

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 ofconsciousness, any major psychiatric disorder including psychosis, major depression,bipolar disorder

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

  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, unless documentation received from prescribing clinician thatanticoagulant medication can be held before LP, and approved by study clinician

  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 casebasis by the study physician)

Study Design

Total Participants: 30
Treatment Group(s): 5
Primary Treatment: Placebo (Insulin Diluent)
Phase: 2
Study Start date:
September 14, 2021
Estimated Completion Date:
September 17, 2024

Study Description

The study will consist of a single site, randomized, double-blind trial comparing the effects of 4 weeks of intranasal insulin(40 International Units four times daily), empagliflozin (10 mg daily) and combined intranasal insulin (INI) and empagliflozin (empa) compared with placebo on cerebrospinal fluid (CSF) biomarkers and cognition.

At study entry, participants will be randomized to one of 4 conditions: INI, empa, INI+empa or placebo. Participants who are cognitively normal but have abnormal elevations of brain amyloid or who have mild cognitive impairment (MCI) or early Alzheimer's disease (AD) will be enrolled.

The primary outcome measure will consist of safety (treatment-related serious adverse events). Secondary outcome measures will consist of cerebrospinal fluid (CSF) biomarkers, cognition, and cerebral blood flow.

Connect with a study center

  • Wake Forest University Health Sciences / Wake Forest School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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