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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.

Register:	ClinicalTrials.gov
Last refreshed on:	13 January 2025
Main ID:	NCT04390009
Date of registration:	12/05/2020
Prospective Registration:	Yes
Primary sponsor:	Brain Health Alliance
Public title:	Entire-body PET Scans for Multiple Sclerosis EPSMS
Scientific title:	Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
Date of first enrolment:	September 30, 2024
Target sample size:	20
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT04390009
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase:	Early Phase 1

Countries of recruitment
United States

Contacts

Name:	Carl Taswell, MD, PhD
Address:
Telephone:	949-481-3121
Email:	ctaswell@brainhealthalliance.org
Affiliation:

Name:	Carl Taswell, MD, PhD
Address:
Telephone:	949-481-3121
Email:	ctaswell@brainhealthalliance.org
Affiliation:

Name:	Carl Taswell, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Brain Health Alliance

Key inclusion & exclusion criteria

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.

Age minimum: 25 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Diagnostic Test: Entire-body PET-CT scans

Drug: Amyvid radiopharmaceutical

Primary Outcome(s)

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]

Secondary Outcome(s)

Secondary ID(s)

BHA-2020-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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