Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease Mild Cognitive Impairment | Drug: All Subjects | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Arm | Intervention/treatment |
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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
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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).
Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for all subjects:
Inclusion Criteria for Healthy Volunteers
Inclusion Criteria for Subjects with a Diagnosis of MCI or Dementia Due to AD
Exclusion Criteria for all subjects
United States, Wisconsin | |
University of Wisconsin-Madison | |
Madison, Wisconsin, United States, 53792 |
Tracking Information | |||||
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First Submitted Date ICMJE | April 15, 2019 | ||||
First Posted Date ICMJE | April 18, 2019 | ||||
Last Update Posted Date | May 19, 2021 | ||||
Actual Study Start Date ICMJE | April 2, 2019 | ||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | This is a longitudinal, observational study evaluating the imaging characteristics of the tau PET radioligand [18F]MK-6240 in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and Healthy Volunteer (HV) subjects. Up to 42 subjects, including approximately 28 MCI/mild AD subjects, up to 5 moderate AD subjects, and 9 similarly aged HV subjects will be consented and screened. Imaging procedures include [11C]PiB to evaluate amyloid deposition, [18F]MK-6240 PET, and structural MRI. All subjects complete an evaluable baseline [18F]MK-6240 PET scan, as well as scans 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Drug: All Subjects
All subjects will be given the experimental tau PET radioligand [18F]MK-6240
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Study Arms ICMJE | 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. Intervention: Drug: All Subjects
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE |
42 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2022 | ||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria for all subjects:
Inclusion Criteria for Healthy Volunteers
Inclusion Criteria for Subjects with a Diagnosis of MCI or Dementia Due to AD
Exclusion Criteria for all subjects
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03919669 | ||||
Other Study ID Numbers ICMJE | 2018-1348 A534255 ( Other Identifier: UW Madison ) SMPH/MEDICINE/GER-AD DEV ( Other Identifier: UW Madison ) Protocol Version June 19 2020 ( Other Identifier: UW Madison ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Wisconsin, Madison | ||||
Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
Collaborators ICMJE | Cerveau Technologies, Inc. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Wisconsin, Madison | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |