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Dementia (DEM) for Alzheimer's Disease (ADNI4 Trial)

N/A
Recruiting
Led By Ronald Petersen, MD, PHD
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 5 years
Awards & highlights

Summary

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.

Eligible Conditions
  • Alzheimer's Disease
  • Dementia
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years 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 enrollment of Underrepresented Populations (URPs)
Secondary outcome measures
Cerebrospinal Fluid
Change in Cerebrospinal Fluid (CSF) Levels of Total Tau
Body Weight Changes
+14 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mild Cognitive Impairment (MCI)Experimental Treatment6 Interventions
450 participants with mild cognitive impairment (MCI), which is anticipated to include 250 newly enrolled participants and 200 rollover participants from the prior ADNI3 study with MCI.
Group II: Dementia (DEM)Experimental Treatment6 Interventions
350 participants with mild dementia (DEM), which is anticipated to include 250 newly enrolled participants and 100 participants followed from the prior ADNI3 study with dementia.
Group III: Cognitively Normal (CN)Experimental Treatment6 Interventions
700 participants with no apparent memory problems, which is anticipated to include 250 newly enrolled participants and 450 rollover participants from the prior ADNI3 study without apparent memory problems.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amyvid
2020
N/A
~10

Find a Location

Who is running the clinical trial?

Alzheimer's Therapeutic Research InstituteOTHER
17 Previous Clinical Trials
56,725 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,053,503 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,611,981 Total Patients Enrolled
~1000 spots leftby Jul 2027
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