TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind

NCT ID: NCT03024944

Last Updated: 2017-12-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2020-01-31

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.

Conditions

Diabetes Mellitus; Alzheimer Dementia

Keywords

Diabetes Mellitus; Alzheimer's Disease; Dementia; THK

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Brain Imaging with 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.

Group Type: EXPERIMENTAL

18F-THK-5351

Intervention Type: DRUG

Intravenous (IV) catheter (tube) placed in participant arm. A small amount of 18F-THK-5351 will be injected into the IV enough time has passed for this contrast to collect in the tissue in the brain (approximately one half-hour), and participant will lie on a bed which slides into a PET Scanner to complete Tau imaging.

Interventions

18F-THK-5351

Intravenous (IV) catheter (tube) placed in participant arm. A small amount of 18F-THK-5351 will be injected into the IV enough time has passed for this contrast to collect in the tissue in the brain (approximately one half-hour), and participant will lie on a bed which slides into a PET Scanner to complete Tau imaging.

Intervention Type: DRUG

Other Intervention Names

THK

Eligibility Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

José A. Luchsinger

Associate Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose A Luchsinger, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

3R01AG050440

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR1419

Identifier Type: -

Identifier Source: org_study_id