Recruiting
Early Phase 1

PET Scanner

Sponsor:

Brain Health Alliance

Code:

NCT04390009

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

Entire-body PET-CT scans

Amyvid radiopharmaceutical

Study Details

Brief summary:

To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.

Conditions

Multiple Sclerosis

Study ID

NCT04390009

Start date

Sep 30, 2024

Status verified date

Oct, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.
  • Normal healthy subjects.
  • Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.

Exclusion Criteria:

  • Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms of MS.
  • Pregnancy or breast feeding.
  • Diabetes or other metabolic-endocrine disorders.
  • Any known concomitant acute infection.
  • History of metastatic or locally invasive cancer.
  • Recent surgery, chemotherapy or radiation therapy.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Siemens Biograph Vision PET-CT scans

Parallel study arms defined by PET-CT scanners by different manufacturer and model

other: United Imaging uEXPLORER PET-CT scans

Parallel study arms defined by PET-CT scanners by different manufacturer and model

Interventions

Entire-body PET-CT scans

Entire-body PET-CT scans will be performed with state-of-the-art scanners with different manufacturers' models including Siemens Biograph Vision, United Imaging uEXPLORER and possibly other recently FDA-approved PET-CT scanners.

Amyvid radiopharmaceutical

Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

Primary outcome measure

  • Entire-body PET imaging of demyelination of peripheral and central nervous system [ Time Frame: During 1 day single PET-CT scan ]
  • Psychometric questionnaire for monitoring psychological health [ Time Frame: Up to 90 days ]

Central Contacts and Locations

Central contacts

Carl Taswell, MD, PhD

949-481-3121ctaswell@brainhealthalliance.org

Locations

Brain Health Alliance

Recruiting

Ladera Ranch, California, United States, 92694

Contacts

Carl Taswell, MD, PhD

949-481-3121ctaswell@brainhealthalliance.org

More Information

Sponsor

Brain Health Alliance

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • Multiple Sclerosis
  • Entire-body PET imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Brain Health Alliance on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.