Exploring the Utility of [18F]3F4AP for Demyelination Imaging

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06999434
Phase
PHASE1
Status
Recruiting
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Conditions

  • Alzheimer's Disease (AD)
  • Demyelinating Disorders
  • MCI
  • MS (Multiple Sclerosis)
  • SCI - Spinal Cord Injury
  • Spinal Radiculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • [ 18F]3F4AP — DRUG
    PET Scan #3
  • [18F]MK6240 — DRUG
    PET Scan #2
  • [11C]PIB — DRUG
    PET Scan #1

Study Details

The overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).

Key Dates

Start date
May 5, 2025
Status verified
May 2025
Primary completion
May 5, 2030
Completion
May 5, 2030

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Healthy Control
    n = 30 - up to three PET scanning sessions.
  • Experimental: Alzheimer's Disease (AD)
    n = 15 - up to three PET scanning sessions.
  • Experimental: Mild Cognitive Impairment (MCI)
    n = 15 - up to three PET scanning sessions.
  • Experimental: Multiple Sclerosis (MS)
    n = 15 - up to three PET scanning sessions.
  • Experimental: Spinal Cord Injury (SCI)
    n = 15 - up to three PET scanning sessions.
  • Experimental: Spinal radiculopathy (SR)
    n = 15 - up to three PET scanning sessions.

Primary Outcome Measure

Tracers volume of distribution (VT) [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University PET CenterNew HavenConnecticut06510-

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Yale University PET Center· New Haven, CT

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