Health Trials

Longitudinal Early-onset Alzheimer's Disease Study Protocol

ConditionsEarly Onset Alzheimer DiseaseAlzheimer DiseaseMild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-64
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

Meets NIA-AA criteria for MCI due to AD or probable AD dementia

Have a global CDR score ≤ 1.0

Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC

Age between 40-64 years (inclusive) at the time of consent

Disqualifiers

Meets core clinical criteria for non-AD dementia

Two or more first degree relatives with a history of early-onset dementia suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2, MAPT, GRN and C9ORF72 have been excluded

Known CLIA certified mutation in an ADAD gene (APP, PSEN1, PSEN2), or other autosomal dominant genes associated with other neurodegenerative disorders (MAPT, GRN, C9ORF72)

Contraindications to 3T MRI (e.g., claustrophobia, pacemaker, select aneurismal clip, artificial heart valve, select ear implants, select stents incompatible with 3T MRI, metal fragments or foreign objects in the eyes, skin or body, etc.)

Trial design

Treatments tested in this trial

  • Flortaucipir
  • Florbetaben
  • Fluorodeoxyglucose

Treatment groups

850 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

Alzheimer's Therapeutic Research Institute

Collaborator

National Institute on Aging (NIA)

Collaborator

Alzheimer's Association

Collaborator

Source ClinicalTrials.gov