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Group B for Alzheimer's Disease (APEX Trial)

N/A
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 12, month 24, month 36 and month 48
Awards & highlights

Summary

The APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. Approximately 1000 participants will be enrolled across three groups: * Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative), * Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and * Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials. Primary Objectives: * Collect longitudinal cognitive and functional assessments and blood-based biomarker data * Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants * Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status Exploratory Objectives: • Collect baseline amyloid PET on participants without prior amyloid PET data (Group C)

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 12, month 24, month 36 and month 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 12, month 24, month 36 and month 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of change from Baseline to Month 48 on plasma phosphorylated tau (ptau) 217
Secondary study objectives
Rate of Change from Baseline to Month 48 as measured Cognitive Function Index (CFI)
Rate of Change from Baseline to Month 48 as measured by the Preclinical Alzheimer Cognitive Composite 5(PACC5)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment1 Intervention
Approximately 250 participants who screen failed prior to PET imaging will undergo amyloid PET imaging with NAV4694 injection.
Group II: Group BExperimental Treatment0 Interventions
Approximately 250 participants who screen failed from the AHEAD study that were plasma negative / PET negative
Group III: Group AExperimental Treatment0 Interventions
Approximately 500 participants who screen failed from the AHEAD study that were plasma positive / PET negative

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,612,481 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,003 Total Patients Enrolled
Alzheimer's Clinical Trials Consortium (ACTC)UNKNOWN
~667 spots leftby Jun 2028
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