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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
NCT02649985 |
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Date of registration:
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06/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's Disease
MAPET |
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Scientific title:
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Microglial Activation Positron Emission Tomography (PET) Brain Imaging in Multiple Sclerosis and Alzheimer's Disease |
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Date of first enrolment:
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May 2, 2016 |
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Target sample size:
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105 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02649985 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Tarun Singhal, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Name:
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Jack Ficke |
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Address:
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Telephone:
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617-264-3044 |
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Email:
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jficke@bwh.harvard.edu |
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Affiliation:
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Name:
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Tarun Singhal, MD |
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Address:
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Telephone:
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617-264-3043 |
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Email:
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tsinghal@bwh.harvard.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male and female subjects age 18 to 70 years. For Alzheimer's Disease patients and
healthy controls, the age range is going to be 18 to 85 years.
2. For RRMS, it needs to be active, which is defined as at least one relapse in the past
12 months, at least one gadolinium enhancing lesion on MRI within 12 months of
enrollment or at least one new FLAIR bright lesion on MRI within 6 months of
enrollment.
3. For SPMS, deterioration in EDSS score in the last year is required.
4. For the subjects in the Ocrelizumab arm, only the subjects who have already been
prescribed Ocrelizumab by their treating MS neurologist but have not yet started the
first infusion, will be included.
5. AD subjects with MMSE score of 20-26.
6. Subjects willing to undergo PET and MRI imaging
7. Subjects willing and able to give informed consent
Exclusion Criteria:
1. Individuals with a known alternate neurologic disorder, previous head injury, or
substance abuse.
2. Individuals with bipolar disease and schizophrenia
3. Concurrent medical conditions that contraindicate study procedures.
4. Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant
or suspects she is pregnant will be excluded from enrollment.
5. Claustrophobia
6. Non-MRI compatible implanted devices
7. For the Ocrelizumab arm, subjects already on Ocrelizumab will be excluded. For the
Alemtuzumab arm, subjects already on Alemtuzumab will be excluded.
8. For the Ocrelizumab arm and the Alemtuzumab arm, subjects with abnormal serum
creatinine will be excluded.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Multiple Sclerosis
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Intervention(s)
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Drug: [F-18]PBR06
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Drug: [C-11]PBR28
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Primary Outcome(s)
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Tissue Volume of Distribution
[Time Frame: 1 month]
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Secondary Outcome(s)
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Standardized uptake values (SUV)/Standardized uptake value Ratios (SUVR)
[Time Frame: 1 month]
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Secondary ID(s)
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2015P002329
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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