Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein
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|ClinicalTrials.gov Identifier: NCT03071224|
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Healthy Volunteers||Drug: [18F] MNI-946 Drug: [18F]Florbetapir||Early Phase 1|
The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
- To measure the dynamic uptake and washout of [18F]MK-6240 in brain using positron emission tomography (PET) in patients with Alzheimer's disease and healthy volunteers.
- To measure blood metabolites of [18F]MK-6240 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input.
- To obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease and healthy volunteers (Cohort 1).
- To acquire safety data following injection of [18F]MK-6240.
- 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.
- To evaluate the correlation between the longitudinal change in tau burden and change in clinical, MRI and CSF biomarker measures in AD subjects and in similarly-aged HV subjects.
- To further explore the relationship between tracer metabolism and smoking (Cohort 3).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease Compared to Healthy Volunteers|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
To evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.
Drug: [18F] MNI-946
Subjects will undergo PET imaging using [18F]MNI-946, a PET radioligand for imaging tau.
Other Name: [18F]MK6240
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.
- 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. [ Time Frame: 1 year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071224
|Contact: Rhea Martinemail@example.com|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
|Contact: Rhea Martin 203-401-4300 firstname.lastname@example.org|
|Principal Investigator: David Russell, MD, PhD|
|Sub-Investigator: Joyce Gibbons, PA-C|
|Principal Investigator:||David Russell, M.D., Ph. D||Invicro|