Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein

NCT03071224 | Completed Early Phase 1

• 1 other identifier: [18F] MNI-946
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this protocol is to evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical.

Conditions

Alzheimer Disease; Healthy Volunteers

Keywords

AD; HV

Outcome Measures

Primary Outcomes (1)

• To determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) compared to baseline in AD subjects and in similarly aged HV subjects.

  Tracer uptake will be evaluated in regions of interest for analysis of regional \[18F\]MK-6240 binding/uptake and expressed in SUV by using established methods for normalization for 12 AD and 3 HV subjects in Cohort 1, 8 AD and 2 HV subjects in Cohort 2, and 3 AD and 3 HV subjects in Cohort 3. Target regions of interest in the standard volume of interest (VOI) template, will be used for tracer uptake quantitation of potentially increased binding to tau pathology will correspond in particular to the cortical regions of the brain. Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MK-6240. Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-946.

  1 year

Study Arms (1)

[18F]MNI-946

EXPERIMENTAL

To evaluate \[18F\]MK-6240 (also known as \[18F\]MNI-946) a tau targeted radiopharmaceutical.

Drug: [18F] MNI-946; Drug: [18F]Florbetapir

Interventions

[18F] MNI-946 DRUG

Subjects will undergo PET imaging using \[18F\]MNI-946, a PET radioligand for imaging tau.

Also known as: [18F]MK6240

[18F]MNI-946

[18F]Florbetapir DRUG

Subjects with Alzheimer's disease will receive a \[18F\]florbetapir scan to compare distribution of tau in the brain compared to that of \[18F\]MNI-946.

[18F]MNI-946

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier method for the duration of the study.
• Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
• Male subjects must not donate sperm for the study duration.
• Willing and able to cooperate with study procedures.
• Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MK-6240 imaging visit.
• No cognitive impairment from neuropsychological battery as judged by the investigator
• Have screening \[18F\]Florbetapir PET imaging demonstrating no significant amyloid binding based on qualitative (visual read).
• No family history of Alzheimer's disease or neurological disease associated with dementia
• Have a CDR global score=0
• Have an MMSE score ≥28
• Willing and able to cooperate with study procedures.
• Males and females aged 50 to 80 years.
• Have probable Alzheimer's disease dementia, based on the NINCDS/ADRDA and DSM-IV criteria, with mild severity and amnestic presentation
• Have a CDR score ≥ 0.5 at screening

You may not qualify if:

• Current or prior history of any alcohol or drug abuse.
• Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
• Subject has received an investigational therapeutic drug or device within 30 days of screening.
• Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
• Pregnancy, lactating or breastfeeding.
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Unsuitable veins for repeated venipuncture.
• Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
• Has received treatment that targeted Aβ or tau within the last 3 months.

Sponsors & Collaborators

• Invicro: lead

Study Sites (1)

Invicro

New Haven, Connecticut, 06510, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

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

Study Officials

• David Russell, M.D., Ph. D

  Invicro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 6, 2017
• Study Start: June 1, 2016
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: June 14, 2021

Record last verified: 2019-09

Locations

US (1)