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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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12 December 2020 |
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Main ID: |
NCT02702102 |
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Date of registration:
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03/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
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Scientific title:
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Imaging Inflammation in Patients With Diffuse Lewy Body Disease |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02702102 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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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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William Kreisl, 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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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Inclusion criteria for patients:
1. Age 60 and older.
2. Meet criteria for either a) dementia with Lewy bodies, or b) Parkinson's disease
dementia.
3. Written and oral fluency in English.
4. Able to participate in all scheduled evaluations and to complete all required
tests and procedures.
5. In the opinion of the investigator, the subject must be considered likely to
comply with the study protocol and to have a high probability of completing the
study.
- Inclusion criteria for controls:
1. Age 60 and older.
2. Normal cognitive and motor function based on neurological examination.
3. Written and oral fluency in English.
4. Able to participate in all scheduled evaluations and to complete all required
tests and procedures.
5. In the opinion of the investigator, the subject must be considered likely to
comply with the study protocol and to have a high probability of completing the
study.
Exclusion Criteria:
1. Past or present history of certain other brain disorders.
2. Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple
serious injuries.
3. Contraindication to MRI scanning.
4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia,
etc.).
5. Exposure to research related radiation in the past year that, when combined with this
study, would place subjects above the allowable limits.
6. Low affinity binding on TSPO genetic screen
7. Currently taking anticoagulant drugs (e.g., warfarin).
8. Women of childbearing potential.
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diffuse Lewy Body Disease
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Parkinson's Disease Dementia
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Dementia With Lewy Bodies
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Intervention(s)
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Drug: 11C-PBR28
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Primary Outcome(s)
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Absolute 11C-PBR28 binding (total distribution volume corrected for free fraction in plasma)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Relative 11C-PBR28 binding
[Time Frame: 1 year]
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Secondary ID(s)
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AAAQ0756
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2P50AG008702-26
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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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