Longitudinal Early-onset Alzheimer's Disease Study Protocol

Part of paid clinical trials in Sun City, Arizona.

Sponsor
Indiana University
Study ID
NCT03507257
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Flortaucipir — DRUG
    All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
  • Florbetaben — DRUG
    All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
  • Fluorodeoxyglucose — DRUG
    All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

Study Details

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Key Dates

Start date
Apr 30, 2018
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
850 participants (estimated)

Arms

  • Arm: Early Onset Alzheimer's Disease (EOAD)
    * Diagnosis of NIA-AA criteria of MCI due to AD or probable AD dementia * Amyloid positive status (florbetaben PET scan with evidence of elevated amyloid as determined by a central read) * CDR score ≤ 1.0 * flortaucipir (18F-AV-1451) PET scanning
  • Arm: Cognitively Normal (CN) Controls
    * Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions and activities of daily living * Mini-Mental State Exam score between 26-30 * CDR score = 0 * flortaucipir (18F-AV-1451) PET scanning
  • Arm: Early Onset non-Alzheimer's Disease (EOnonAD)
    * Diagnosis of NIA-AA criteria of MCI due to AD or probable AD dementia * Amyloid negative status (florbetaben PET scan with no evidence of elevated amyloid as determined by a central read) * CDR score ≤ 1.0 * flortaucipir (18F-AV-1451) PET scanning

Primary Outcome Measure

Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) [ Time Frame: Month 0, Month 12, Month 24, Month 36 (EOAD/EOnonAD only) and Month 48 (EOAD/EOnonAD only) ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Banner Sun Health Research InstituteSun CityArizona85351-
University of California, Los AngelesLos AngelesCalifornia90095
Lauren Garcia, MPH
[email protected]
310-794-6191
Leila Parand, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Stephanie Tran
[email protected]
650-521-7287
Sharon Sha, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94121
Karen Smith
[email protected]
415-353-3266
Gil Rabinovici, MD (PRINCIPAL_INVESTIGATOR)
Georgetown UniversityWashington D.C.District of Columbia20057-
Mayo Clinic, JacksonvilleJacksonvilleFlorida32224
Anton Thomas
[email protected]
904-953-4096
Gregory Day, MD (PRINCIPAL_INVESTIGATOR)
Wien CenterMiami BeachFlorida33140-
Emory UniversityAtlantaGeorgia30322
Jennifer Chung
[email protected]
404-712-0195
Erik Johnson, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611-
Indiana UniversityIndianapolisIndiana47405
IU LEADS Team
[email protected]
317-963-7436
Liana Apostolova, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21218
Fiona Sweeney
[email protected]
410-929-2241
Chiadi Onyike, MBBS, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Samuel Murdock
[email protected]
617-643-5568
Brad Dickerson, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic, RochesterRochesterMinnesota55905
Emily Berg
[email protected]
507-293-5669
David Jones, MD (PRINCIPAL_INVESTIGATOR)
Washington University, St. LouisSt LouisMissouri63130
Jessica Wold
[email protected]
314-286-1726
Kyle Womack, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Arlene Mejia
[email protected]
212-305-9168
Lawrence Honig, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Laura Schankel
[email protected]
215-349-8727
David Wolk, MD (PRINCIPAL_INVESTIGATOR)
Butler HospitalProvidenceRhode Island02906
Outreach Team
[email protected]
401-455-6402
Meghan Riddle, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Chimaoge Onyechi
[email protected]
713-363-7729
Joseph Masdeu, MD, PhD (PRINCIPAL_INVESTIGATOR)

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