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NCT05081219 · ClinicalTrials.gov registry record · Phase 2

SNIFF - Combo INI+EMPA Trial

A Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
47
Enrollment target
1
Study location

NCT05081219 is a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 47 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05081219, a Phase 2 study of Alzheimer Disease and Mild Cognitive Impairment, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
47 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Empagliflozin 10 MG
  • DRUG Insulin (Humulin® R U-100)
  • DEVICE Aptar Pharma CPS Intranasal Delivery Device
  • DRUG Placebo (Insulin Diluent)
  • DRUG Placebo (Capsules)

Study Locations (1)

North Carolina

  • Wake Forest University Health Sciences / Wake Forest School of Medicine - Winston-Salem

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2021-09-14
Est. Completion 2024-09-17
Phase Phase 2

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT05081219

The ClinicalTrials.gov registry entry for NCT05081219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 5 interventions - of which Empagliflozin 10 MG is the first listed.

NCT05081219 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05081219 about?

NCT05081219 is a clinical study titled "SNIFF - Combo INI+EMPA Trial". 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 dysfu...

What is the current status of trial NCT05081219?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2021-09-14. Estimated completion is 2024-09-17.

What conditions does trial NCT05081219 study?

This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Cognitive Impairment.

What interventions are being tested in trial NCT05081219?

The interventions under investigation include: Empagliflozin 10 MG (DRUG), Insulin (Humulin® R U-100) (DRUG), Aptar Pharma CPS Intranasal Delivery Device (DEVICE), Placebo (Insulin Diluent) (DRUG), Placebo (Capsules) (DRUG).

Who is sponsoring clinical trial NCT05081219?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05081219 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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