Brain Imaging in the Diabetes Prevention Program Outcomes Study

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.

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03757910

Acronym

DPPOS-Brain

Enrollment

Registered

2018-11-29

Start date

2019-10-01

Completion date

2023-01-31

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Metformin, Pre-diabetes, Type 2 diabetes, DPPOS

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.

Interventions

DRUG18F-MK-6240

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

DRUG11C-PIB

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Brain Amyloid SUVR	Up to 1 hour post-injection	Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)
Brain Tau SUVR	Up to 1 hour post-injection	Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes

Secondary

Measure	Time frame	Description
White Matter Hyper Intensity Volume	Up to 1 hour post-injection	Volume of brain white matter hyper-intensities
Hippocampal Cortical Thickness	Up to 1 hour post-injection	Thickness in the hippocampal cortex

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026