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NCT02649985 · ClinicalTrials.gov registry record · Phase 1
PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
A Phase 1 study of Multiple Sclerosis and Alzheimers Disease, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT02649985: Recruiting Phase 1 study of Multiple Sclerosis and Alzheimers Disease, sponsored by Brigham and Women's Hospital.
NCT02649985 is a Phase 1 study of Multiple Sclerosis and Alzheimers Disease that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 250 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02649985, a Phase 1 study of Multiple Sclerosis and Alzheimers Disease, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2. A pilot substudy aims to establish the non-inferiority of \[F-18\]PBR06 as compared with Carbon-11 \[C-11\] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard.
Primary Outcome
PET imaging measurement
Conditions Studied
Interventions
- DRUG [F-18]PBR06
- DRUG [C-11]PBR28
Study Locations (1)
Massachusetts
- Brigham MS Center, 60 Fenwood Road - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2016-05-02 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT02649985 shows while recruiting
NCT02649985 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which [F-18]PBR06 is the first listed.
NCT02649985 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02649985 about?
NCT02649985 is a clinical study titled "PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases". The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary ...
What is the current status of trial NCT02649985?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2016-05-02. Estimated completion is 2027-12-31.
What conditions does trial NCT02649985 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Alzheimers Disease.
What interventions are being tested in trial NCT02649985?
The interventions under investigation include: [F-18]PBR06 (DRUG), [C-11]PBR28 (DRUG).
Who is sponsoring clinical trial NCT02649985?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02649985 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02649985's enrollment target sits among peer trials
250 67th of 315 higher than 246 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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