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Early Onset non-Alzheimer's Disease (EOnonAD) for Alzheimer's Disease (LEADS Trial)

N/A
Recruiting
Led By Liana Apostolova, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cn participants: month 0 and month 24; eoad/eononad participants: month 0, month 12, month 24, month 36 and month 48
Awards & highlights

Summary

This trial is designed to look at how Alzheimer's Disease progresses in people with early onset cognitive impairment, comparing them to people with early onset non-Alzheimer's Disease and cognitively normal controls.

Eligible Conditions
  • Alzheimer's Disease
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cn participants: month 0 and month 24; eoad/eononad participants: month 0, month 12, month 24, month 36 and month 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and cn participants: month 0 and month 24; eoad/eononad participants: month 0, month 12, month 24, month 36 and month 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)
Secondary outcome measures
Rate of change in cognition as measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Early Onset non-Alzheimer's Disease (EOnonAD)Experimental Treatment3 Interventions
* 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
Group II: Early Onset Alzheimer's Disease (EOAD)Experimental Treatment2 Interventions
* 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
Group III: Cognitively Normal (CN) ControlsExperimental Treatment3 Interventions
* 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Florbetaben
2020
Completed Phase 2
~550
Fluorodeoxyglucose
2017
Completed Early Phase 1
~20
Flortaucipir
2011
N/A
~1190

Find a Location

Who is running the clinical trial?

Alzheimer's AssociationOTHER
95 Previous Clinical Trials
41,600 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,303 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,113,515 Total Patients Enrolled
~66 spots leftby May 2025
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