NCT02649985: MAPET

PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases

Recruiting now Phase 1, PHASE2 Last updated 28 January 2026

What this trial tests

Phase 1, PHASE2 trial testing [F-18]PBR06 in Multiple Sclerosis in 250 participants. Currently enrolling.

Timeline

2 May 2016

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	250
Start date	2 May 2016
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• [F-18]PBR06 — full drug profile →
• [C-11]PBR28 — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 85, any sex, with Multiple Sclerosis or Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gray matter microglial activation in relapsing vs progressive MS: A [F-18]PBR06-PET study.
   Singhal T, O'Connor K, Dubey S, Pan H, et al · · 2019 · cited 37× · PMID 31355321 · DOI 10.1212/nxi.0000000000000587
2. The Role of Advanced Magnetic Resonance Imaging Techniques in Multiple Sclerosis Clinical Trials.
   Mahajan KR, Ontaneda D. · · 2017 · cited 25× · PMID 28770481 · DOI 10.1007/s13311-017-0561-8
3. Novel PET Imaging of Inflammatory Targets and Cells for the Diagnosis and Monitoring of Giant Cell Arteritis and Polymyalgia Rheumatica.
   van der Geest KSM, Sandovici M, Nienhuis PH, Slart RHJA, et al · · 2022 · cited 21× · PMID 35733858 · DOI 10.3389/fmed.2022.902155
4. Regional microglial activation in the substantia nigra is linked with fatigue in MS.
   Singhal T, Cicero S, Pan H, Carter K, et al · · 2020 · cited 13× · PMID 32769103 · DOI 10.1212/nxi.0000000000000854
5. Translational molecular imaging and drug development in multiple sclerosis.
   Tay D, Ahmed H, Dawoud A, Salam M, et al · · 2026 · PMID 41356192 · DOI 10.7150/thno.119559