Clinical trial

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.

Name

AAAS1176

Description

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.

Trial arms

Trial start

2019-10-01

Estimated PCD

2023-01-31

Trial end

2023-01-31

Status

Terminated

Phase

Early phase I

Treatment

18F-MK-6240

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

Arms:

DPPOS Exposed to Metformin, DPPOS Exposed to Placebo

11C-PIB

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

Arms:

DPPOS Exposed to Metformin, DPPOS Exposed to Placebo

Other names:

11C-Pittsburgh Compound B

Size

Primary endpoint

Brain Amyloid SUVR

Up to 1 hour post-injection

Brain Tau SUVR

Up to 1 hour post-injection

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

Updated at

2024-03-04

1 organization

2 products

1 indication

Organization

Product

Indication

Product