A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03919669|
Recruitment Status : Enrolling by invitation
First Posted : April 18, 2019
Last Update Posted : October 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment||Drug: All Subjects||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Evaluation of [18-F]MK-6240 as a Novel Tau PET Radiotracer in Patients With Alzheimer's Disease Dementia or Mild Cognitive Impairment Compared to Healthy Volunteers|
|Actual Study Start Date :||April 2, 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: All Subjects
All subjects will complete PET imaging sessions evaluating the tau PET radioligand [18F]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline.
If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.
Drug: All Subjects
All subjects will be given the experimental tau PET radioligand [18F]MK-6240
- Change in [18F]MK-6240 uptake [ Time Frame: Baseline to 12 months ]Composite and regional SUVR, voxel based statistics or change in tau distribution
- Correlate the changes in [18F]MK-6240 uptake and changes in clinical cognitive assessments by Mini-Mental Status Exam (MMSE) [ Time Frame: Baseline to 12 months ]The MMSE is a sensitive, valid and reliable 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used as screening tool for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus, making it an effective way to document an individual's response to treatment.
- Correlate the changes in [18F]MK-6240 uptake and changes in clinical cognitive assessments by Clinical Dementia Rating Scale (CDR). [ Time Frame: Baseline to 12 months ]
CDR was developed primarily for use in persons with dementia of the Alzheimer type. The six domains of CDR are: Memory, Orientation, Judgment and Problem-solving, Community Affairs, Home and Hobbies, and Personal Care.
Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available).
- Correlate the changes in [18F]MK-6240 uptake and changes in clinical cognitive assessments by Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline to 12 months ]The ADAS-Cog is one of the most frequently used tests to measure cognition in clinical trials in AD. The ADAS-Cog is a more thorough battery than the Mini Mental State Exam, and primarily measures language and verbal episodic memory. The ADAS-Cog consists of 13 items and takes approximately 25 minutes to administer. The ADAS was developed as a two-part scale: one that measured cognitive functions and one that measured non-cognitive functions such as mood and behavior. Most current research, including this study, uses the ADAS-Cog, which is the sub-scale that measures cognitive ability.
- Change in [18F]MK-6240 uptake [ Time Frame: Baseline to 24 months ]Descriptive statistics will be used to describe the tau deposition (e.g. composite and regional SUVR, voxel based statistics or change in tau distribution) using [18F]MK-6240 PET.
- Change in the Cross-sectional comparison of [18F]MK-6240 uptake [ Time Frame: Baseline, 6 months, 12 months, and 24 months. ]Change in the cross-sectional comparison of [18F]MK-6240 uptake in Alzheimer's disease, Mild Cognitive Impairment, and healthy volunteers will be studied
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): NCT03919669
|United States, Wisconsin|
|University of Wisconsin-Madison|
|Madison, Wisconsin, United States, 53792|