TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind

Phase 2

Withdrawn

• Conditions: Diabetes Mellitus; Alzheimer Dementia
• Interventions: Drug: 18F-THK-5351

• Registration Number: NCT03024944
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this project is to study brain imaging of a substance called tau, which is found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes status (type 2 diabetes \[referred to as diabetes\] and pre-diabetes, compared with normal glucose tolerance \[NGT\]), is associated with increased tau accumulation in the brain, one of the culprits of Alzheimer's disease, in a community-based group of middle aged Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau positron emission tomography (PET) imaging in 30 middle aged Hispanics.

Detailed Description

The burden of late onset Alzheimer's dementia (LOAD) and its antecedents is increasing without known prevention or cure, and diabetes seems to be one of the strongest risk factors. The predominating causal model in Alzheimer's disease (AD) research is based on the amyloid hypothesis, which posits that amyloid (A) deposition in the brain causes synaptic dysfunction resulting in early memory deficits and progression to mild cognitive impairment (MCI) and dementia. Tau has also gained increasing interest as an AD pathology feature, biomarker, and treatment target.

There are no known curative or preventive measures for LOAD. One of the strongest potential LOAD risk factors is type 2 diabetes, an abnormal elevation of blood glucose associated with microvascular and macrovascular complications including cerebrovascular disease. Many studies have reported an association of diabetes with dementia, including LOAD and vascular dementia (VD). Most studies have found that diabetes is associated with an increased risk of both LOAD and VD, with a stronger association for VD compared with LOAD. Thus, this study focuses on the relation of diabetes, pre-diabetes, and elevated glucose, with AD.

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Status Verified: 2017-12
• Study Start: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-29
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All persons who have undergone magnetic resonance imaging (MRI) and amyloid PET already, or those who prospectively are deemed eligible for the parent study covered under protocol AAAQ2950, will be approached for participation.

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Exclusion Criteria

• Person who are not participating in the MRI and amyloid PET under protocol AAAQ2950

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain Imaging with 18F-THK-5351	18F-THK-5351	This group consists of 30 adult subjects: 10 with Type 2 diabetes, 10 with pre-diabetes, and 10 with normal glucose tolerance. Each subject will receive a baseline scan and a follow-up PET scan with 18F-THK-5351.

Primary Outcome Measures

Name	Time	Method
Amount of Tau Accumulation by Measuring Standardized Uptake Value Ratio (SUVR)	2 Years	The primary aim is to measure 18THK-5351 binding (SUVR) in medial temporal and inferior temporal cortex, cross-sectionally and longitudinally.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States