Brain Imaging in the Diabetes Prevention Program Outcomes Study

Alzheimer Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03757910
• Other study ID #: AAAS1176
• Secondary ID: 3U01DK048404-25S
• Status: Terminated
• Phase: Early Phase 1
• Start date: October 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• 18F-MK-6240
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).
• 11C-PIB
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
José A. Luchsinger	Albert Einstein College of Medicine, George Washington University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Amyloid SUVR	Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)	Up to 1 hour post-injection
Primary	Brain Tau SUVR	Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes	Up to 1 hour post-injection
Secondary	Hippocampal Cortical Thickness	Thickness in the hippocampal cortex	Up to 1 hour post-injection
Secondary	White Matter Hyper Intensity Volume	Volume of brain white matter hyper-intensities	Up to 1 hour post-injection