Imaging Tau in Alzheimer's Disease and Normal Aging

NCT02884492 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: AAAQ78681K23AG052633-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.

Conditions

Alzheimer's Disease

Keywords

inflammation; aging; mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 18F-THK-5351 Standardized Uptake Value Ratio

  The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-THK-5351 PET scan in the posterior cingulate gyrus, divided by that in the cerebellar gray matter (the reference region, which is expected to be devoid of tau pathology). This ratio is a relative measure of 18F-THK-5351 binding, and therefore of tau pathology, in brain tissue. PET image data was acquired from 50 min post-injection to 70 min post-injection of 18F-THK-5351.

  PET image data collected 50 min post-injection to 70 min post-injection of 18F-THK-5351

Study Arms (2)

Cognitive impairment

EXPERIMENTAL

Adults with Alzheimer's disease, preclinical Alzheimer's disease or impairment due to suspected non-Alzheimer's disease pathophysiology will receive 18F-THK- 5351 and/or lumbar puncture (optional).

Drug: 18F-THK-5351; Procedure: Lumbar Puncture (optional)

No cognitive impairment

ACTIVE COMPARATOR

Normal aging adults will receive 18F-THK- 5351 and/or lumbar puncture (optional).

Drug: 18F-THK-5351; Procedure: Lumbar Puncture (optional)

Interventions

18F-THK-5351 DRUG

18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.

Also known as: [18F] THK5351

Cognitive impairment; No cognitive impairment

Lumbar Puncture (optional) PROCEDURE

Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.

Cognitive impairment; No cognitive impairment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 and older.
• Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
• Subjects unable to provide informed consent must have a surrogate decision maker.
• Written and oral fluency in English or Spanish.
• Able to participate in all scheduled evaluations and to complete all required tests and procedures.
• In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

You may not qualify if:

• Past or present history of certain brain disorders other than MCI or AD.
• Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
• Contraindication to MRI scanning.
• Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
• History of kidney disease or presence of impaired kidney function based on laboratory tests at the screening visit.
• History of liver disease or presence of impaired liver function based on laboratory tests at the screening visit.
• Participation in the last year in a clinical trial for a disease-modifying drug for AD.
• Inability to have a catheter in subject's vein for the injection of radioligand.
• Inability to have blood drawn from subject's veins.

Sponsors & Collaborators

• William Charles Kreisl: 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

Alzheimer Disease; Inflammation; Cognitive Dysfunction

Interventions

THK5351; Spinal Puncture

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. THK-5351 has been found to bind to monoamine oxidase B as well as to tau aggregates.

Results Point of Contact

• Title: William C. Kreisl, MD
• Organization: Columbia University Medical Center (Taub Institute)

wck2107@cumc.columbia.edu

212-305-9194

Study Officials

• William C Kreisl, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 31, 2016
• Study Start: July 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 19, 2018
• Results First Posted: November 19, 2018

Record last verified: 2018-11

Locations

US (1)