Brain Imaging in the Diabetes Prevention Program Outcomes Study

NCT03757910 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: AAAS11763U01DK048404-25S1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10 persons randomized to placebo in DPP. All study procedures will be conducted at Columbia University Irving Medical Center. Eligible participants will receive a PET scans and a brain MRI, which may be conducted in one, two, or three separate visits.

Conditions

Alzheimer Disease

Keywords

Metformin; Pre-diabetes; Type 2 diabetes; DPPOS

Outcome Measures

Primary Outcomes (2)

• Brain Amyloid SUVR

  Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)

  Up to 1 hour post-injection

• Brain Tau SUVR

  Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes

  Up to 1 hour post-injection

Secondary Outcomes (2)

• Hippocampal Cortical Thickness

  Up to 1 hour post-injection

• White Matter Hyper Intensity Volume

  Up to 1 hour post-injection

Study Arms (2)

DPPOS Exposed to Metformin

EXPERIMENTAL

DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB.

Drug: 18F-MK-6240; Drug: 11C-PIB

DPPOS Exposed to Placebo

ACTIVE COMPARATOR

DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB.

Drug: 18F-MK-6240; Drug: 11C-PIB

Interventions

18F-MK-6240 DRUG

This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).

DPPOS Exposed to Metformin; DPPOS Exposed to Placebo

11C-PIB DRUG

This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.

Also known as: 11C-Pittsburgh Compound B

DPPOS Exposed to Metformin; DPPOS Exposed to Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active participants in the Diabetes Prevention Program Outcomes Study (DPPOS) in New York City originally randomized to metformin or placebo
• years and older

You may not qualify if:

• Known dementia
• Contraindications to magnetic resonance imaging (MRI)
• Contraindications to radio-contrast agents.

Sponsors & Collaborators

• José A. Luchsinger: lead
• Albert Einstein College of Medicine: collaborator
• George Washington University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Glucose Intolerance; Diabetes Mellitus, Type 2

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Jose A. Luchsinger, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: October 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

US (1)