SNIFF - Combo INI+EMPA Trial

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05081219
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Insulin (Humulin® R U-100) — DRUG
    Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
  • Empagliflozin 10 MG — DRUG
    Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily.
  • Aptar Pharma CPS Intranasal Delivery Device — DEVICE
    Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
  • Placebo (Insulin Diluent) — DRUG
    Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
  • Placebo (Capsules) — DRUG
    Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily.

Study Details

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.

Key Dates

Start date
Sep 14, 2021
Status verified
Sep 2024
Primary completion
Sep 17, 2024
Completion
Sep 17, 2024

Study Design

Enrollment
47 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intranasal Insulin and Empagliflozin Placebo
    * 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily * Placebo capsules taken by mouth 30 minutes before breakfast once daily
  • Experimental: Empagliflozin and Intranasal Insulin Placebo
    * Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily * 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily
  • Experimental: Intranasal Insulin and Empagliflozin
    * 40 IU of intranasal insulin administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily * Empagliflozin 10 mg capsules taken by mouth 30 minutes before breakfast once daily
  • Placebo Comparator: Placebo
    * 40 IU of intranasal insulin diluent (placebo) administered using the Aptar CPS device 30 minutes prior to eating and 30 minutes before bedtime for a total of four (4) times daily * Placebo capsules taken by mouth 30 minutes before breakfast once daily

Primary Outcome Measure

Number of Participants With Treatment-Related Serious Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: Week 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health Sciences / Wake Forest School of MedicineWinston-SalemNorth Carolina27157-

Related coverage on Hipa.ai

Find similar trials in Winston-Salem, NC

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Wake Forest University Health Sciences / Wake Forest School of Medicine· Winston-Salem, NC

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