TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind

NCT03024944 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: AAAR14193R01AG050440
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Alzheimer Dementia

Keywords

Diabetes Mellitus; Alzheimer's Disease; Dementia; THK

Outcome Measures

Primary Outcomes (1)

• Amount of Tau Accumulation by Measuring Standardized Uptake Value Ratio (SUVR)

  The primary aim is to measure 18THK-5351 binding (SUVR) in medial temporal and inferior temporal cortex, cross-sectionally and longitudinally.

  2 Years

Study Arms (1)

Brain Imaging with 18F-THK-5351

EXPERIMENTAL

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.

Drug: 18F-THK-5351

Interventions

18F-THK-5351 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.

Also known as: THK

Brain Imaging with 18F-THK-5351

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Dementia

Interventions

THK5351

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose A Luchsinger, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: December 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

US (1)