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Brain Imaging in the Diabetes Prevention Program Outcomes Study (DPPOS-Brain)

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-MK-6240
11C-PIB
Sponsored by
José A. Luchsinger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Metformin, Pre-diabetes, Type 2 diabetes, DPPOS

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Columbia University Medical Center
  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DPPOS Exposed to Metformin

DPPOS Exposed to Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Brain Amyloid SUVR
Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)
Brain Tau SUVR
Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes

Secondary Outcome Measures

Hippocampal Cortical Thickness
Thickness in the hippocampal cortex
White Matter Hyper Intensity Volume
Volume of brain white matter hyper-intensities

Full Information

First Posted
November 27, 2018
Last Updated
July 8, 2021
Sponsor
José A. Luchsinger
Collaborators
Albert Einstein College of Medicine, George Washington University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03757910
Brief Title
Brain Imaging in the Diabetes Prevention Program Outcomes Study
Acronym
DPPOS-Brain
Official Title
Amyloid Brain Positron Emission Tomography (PET) Imaging With 11C-PIB and Tau PET Imaging With 18F-MK-6240 in the Diabetes Prevention Program Outcomes Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
José A. Luchsinger
Collaborators
Albert Einstein College of Medicine, George Washington University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Hyperinsulinemia is believed to increase the risk of Alzheimer's dementia through both cerebrovascular and A related mechanisms, and this hypothesis has prompted testing strategies related to hyperinsulinemia and diabetes in the prevention and treatment of Alzheimer's dementia.These strategies usually entail improving insulin sensitivity to lower insulin and glucose levels, such as lifestyle (diet and exercise) and metformin, which were effective strategies for preventing diabetes in the DPPOS. There are conflicting data relating metformin with increased AD risk, and this needs to be clarified in DPPOS. Several laboratory and human studies have suggested that metformin increases the risk of Alzheimer's dementia, but this is countered by other studies indicating that it is beneficial. Preliminary data in humans and animals support the beneficial effects of metformin on Alzheimer's dementia risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Metformin, Pre-diabetes, Type 2 diabetes, DPPOS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DPPOS Exposed to Metformin
Arm Type
Experimental
Arm Description
DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB.
Arm Title
DPPOS Exposed to Placebo
Arm Type
Active Comparator
Arm Description
DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB.
Intervention Type
Drug
Intervention Name(s)
18F-MK-6240
Intervention Description
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).
Intervention Type
Drug
Intervention Name(s)
11C-PIB
Other Intervention Name(s)
11C-Pittsburgh Compound B
Intervention Description
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
Primary Outcome Measure Information:
Title
Brain Amyloid SUVR
Description
Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)
Time Frame
Up to 1 hour post-injection
Title
Brain Tau SUVR
Description
Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes
Time Frame
Up to 1 hour post-injection
Secondary Outcome Measure Information:
Title
Hippocampal Cortical Thickness
Description
Thickness in the hippocampal cortex
Time Frame
Up to 1 hour post-injection
Title
White Matter Hyper Intensity Volume
Description
Volume of brain white matter hyper-intensities
Time Frame
Up to 1 hour post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active participants in the Diabetes Prevention Program Outcomes Study (DPPOS) in New York City originally randomized to metformin or placebo 60 years and older Exclusion Criteria: Known dementia Contraindications to magnetic resonance imaging (MRI) Contraindications to radio-contrast agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. X. Pi-Sunyer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Albert Einstein College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Brain Imaging in the Diabetes Prevention Program Outcomes Study

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