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

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ClinicalTrials.gov Identifier: NCT03757910
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
Albert Einstein College of Medicine, Inc.
George Washington University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
José A. Luchsinger, Columbia University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: 18F-MK-6240 Drug: 11C-PIB Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: DPPOS Exposed to Metformin
DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB.
Drug: 18F-MK-6240
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).

Drug: 11C-PIB
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
Other Name: 11C-Pittsburgh Compound B

Active Comparator: DPPOS Exposed to Placebo
DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB.
Drug: 18F-MK-6240
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).

Drug: 11C-PIB
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
Other Name: 11C-Pittsburgh Compound B




Primary Outcome Measures :
  1. Brain Amyloid SUVR [ Time Frame: Up to 1 hour post-injection ]
    Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)

  2. Brain Tau SUVR [ Time Frame: Up to 1 hour post-injection ]
    Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes


Secondary Outcome Measures :
  1. Hippocampal Cortical Thickness [ Time Frame: Up to 1 hour post-injection ]
    Thickness in the hippocampal cortex

  2. White Matter Hyper Intensity Volume [ Time Frame: Up to 1 hour post-injection ]
    Volume of brain white matter hyper-intensities



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757910


Contacts
Contact: Jose A. Luchsinger, MD 212-305-4730 jal94@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Jose A Luchsinger, MD    212-305-4730    jal94@cumc.columbia.edu   
Principal Investigator: Jose A Luchsinger, MD         
Sub-Investigator: F X Pi-Sunyer, MD         
Albert Einstein College of Medicine Not yet recruiting
New York, New York, United States, 10461
Principal Investigator: Jill Crandall, MD         
Sponsors and Collaborators
José A. Luchsinger
Albert Einstein College of Medicine, Inc.
George Washington University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: F. X. Pi-Sunyer, MD Columbia University

Responsible Party: José A. Luchsinger, Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT03757910     History of Changes
Other Study ID Numbers: AAAS1176
3U01DK048404-25S1 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by José A. Luchsinger, Columbia University:
Metformin
Pre-diabetes
Type 2 diabetes
DPPOS

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs