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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

This trial accepts healthy volunteers

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 population

Cognitively Impaired Participants (ie: Early Onset Alzheimer's Disease (EOAD) and Early Onset non-Alzheimer's Disease (EOnonAD)) and Cognitively Normal (CN) Control Participants

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

850 Participants
are divided into 3 treatment groups
Group A: Early Onset Alzheimer's Disease (EOAD)2 interventions
Group B: Cognitively Normal (CN) Controls3 interventions
Group C: Early Onset non-Alzheimer's Disease (EOnonAD)3 interventions

Trial outcomes

Primary outcomes

1

Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)

The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained.

Time frame
Month 0, Month 12, Month 24, Month 36 (EOAD/EOnonAD only) and Month 48 (EOAD/EOnonAD only)

Secondary outcomes

1

Rate of change in cognition as measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB)

The CDR is a semi-structured interview of the informant and participant that assesses for impairment in 8 areas of functioning - memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care, behavior, personality, and language.

Time frame
CN participants: Month 0 and Month 24; EOAD/EOnonAD participants: Month 0, Month 12, Month 24, Month 36 and Month 48
2

Change in tau deposition as measured by flortaucipir (18F-AV-1451) Positron Emission Tomography (PET) imaging

Time frame
Month 0, Month 12 (EOAD only), Month 24 (EOAD only) and Month 36 (EOAD and EOnonAD amyloid positive participants only)
3

Change in amyloid deposition as measured by florbetaben using Positron Emission Tomography (PET) imaging

Time frame
Month 0, Month 12 (EOAD only), Month 24 (EOAD only) and Month 36 (EOAD/EOnonAD only
4

Neurodegeneration as measured by fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging compared to magnetic resonance imaging (MRI)

Time frame
Month 12 (EOnonAD only) and Month 24 (CN only)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Alzheimer's Therapeutic Research Institute

Collaborator

National Institute on Aging (NIA)

Collaborator

Alzheimer's Association

Collaborator

Source ClinicalTrials.gov
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