Clinical trial NCT03757910: Brain Imaging in the Diabetes Prevention Program Outcomes Study
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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Keywords: Metformin
Pre-diabetes
Type 2 diabetes
DPPOS
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: George Washington University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-11-29
Enrollment: 5
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Brain Amyloid SUVR
timeFrame: Up to 1 hour post-injection
measure: Brain Tau SUVR
timeFrame: Up to 1 hour post-injection
Secondary outcomes:
measure: Hippocampal Cortical Thickness
timeFrame: Up to 1 hour post-injection
measure: White Matter Hyper Intensity Volume
timeFrame: Up to 1 hour post-injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jose A. Luchsinger, MD
role: PRINCIPAL_INVESTIGATOR
References: