Imaging Tau in Alzheimer's Disease and Normal Aging

NCT03373604 | Completed Phase 2 Results DMC FDA Drug

• 6 other identifiers: AAAR4352K23AG052633-022R56AG034189-06A1K24AG045334R01AG055299R01AG050440-02S1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to learn about tau tangles in Alzheimer's disease. A type of positron emission tomography (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 Disease

Keywords

18F-MK-6240; Cognitive Impairment; Alzheimer's

Outcome Measures

Primary Outcomes (1)

• 18F-MK-6240 Binding

  Standardized uptake value ratio (SUVr)

  1 day

Secondary Outcomes (1)

• Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.

  One year follow-up

Study Arms (2)

Cognitive impairment

EXPERIMENTAL

Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)

Drug: 18F-MK-6240; Procedure: Lumbar Puncture (optional)

No cognitive impairment

ACTIVE COMPARATOR

Healthy controls

Drug: 18F-MK-6240; Procedure: Lumbar Puncture (optional)

Interventions

18F-MK-6240 DRUG

18F-MK-6240 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]-MK6240

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 - 100 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
• amnestic mild cognitive impairment (MCI) (single or mixed domain) or mild Alzheimer's disease (AD), or
• 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 magnetic resonance imaging (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 screening visit.
• History of liver disease or presence of impaired liver function based on laboratory tests at 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

• Patrick Lao: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149.

  PMID: 33646153 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; 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

Results Point of Contact

• Title: Patrick Lao, PhD
• Organization: Columbia University

pjl2133@cumc.columbia.edu

212-342-1399

Study Officials

• Patrick Lao, PhD

  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: Assistant Professor of Neurological Sciences

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 14, 2017
• Study Start: December 11, 2017
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Locations

US (1)