[18F]PI-2620 Phase 3 Histopathological Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Lantheus Biosciences Ltd.
Study ID
NCT05641688
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]PI-2620 — DRUG
    The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%

Study Details

This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with \[18F\]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy.

Key Dates

Start date
Dec 1, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: PI-2620 PET Scan

Primary Outcome Measure

Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative) [ Time Frame: At autopsy, until study completion with an average of 1 year ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013-
Banner Sun Health Research InstituteSun CityArizona85352-
UC Los AngelesLos AngelesCalifornia90095 - 7370-
Esperanza ClinicalMurrietaCalifornia92562-
Sutter HealthSan FranciscoCalifornia94114-
Galiz ResearchHialeahFlorida33016-
UF College of Medicine - JacksonvilleJacksonvilleFlorida32209-
K2 Medical ResearchLady LakeFlorida32159-
K2 Medical ResearchMaitlandFlorida32751-
ClinCloud ResearchMelbourneFlorida32940-
Miami Jewish Health SystemsMiamiFlorida33137-
The Roskamp InstituteSarasotaFlorida34243-
Charter ResearchWinter ParkFlorida32792-
Alzheimer's Disease CenterBraintreeMassachusetts02184-
Headlands ResearchPlymouthMassachusetts02360-
Be Well Clinical StudiesLincolnNebraska68616-
Darthmouth-Hitchcock Medical CenterLebanonNew Hampshire07366-
Velocity Clinical ResearchEast SyracuseNew York13057-
Ichor ResearchSyracuseNew York13219-
American Carolina Clinical Research LLCCharlotteNorth Carolina28273-
Insight Clinical Trials LLCBeachwoodOhio44131-
Valley Medical ResearchCentervilleOhio45459-
Baylor Research InstituteDallasTexas75231-
Sante Clinical ResearchKerrvilleTexas78028-
Be Well Clinical StudiesRound RockTexas78681-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Barrow Neurological Institute· Phoenix, AZBanner Sun Health Research Institute· Sun City, AZUC Los Angeles· Los Angeles, CAEsperanza Clinical· Murrieta, CASutter Health· San Francisco, CAGaliz Research· Hialeah, FL

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