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NCT04468659 · ClinicalTrials.gov registry record · Phase 3
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
A Phase 3 study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, sponsored by Eisai.
- Active
- Registry status
- Phase 3
- Development phase
- 1,400
- Enrollment target
- 20
- Study locations
NCT04468659: Active Phase 3 study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, sponsored by Eisai.
NCT04468659 is a Phase 3 study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease that is active but no longer recruiting, run by Eisai. The registered enrollment target is 1,400 participants, above the 512-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (173% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04468659, a Phase 3 study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, is active but no longer recruiting, sponsored by Eisai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,400 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.
Primary Outcome
PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0\[worst\]-96\[best recall\]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0\[worst\]-25\[best recall\]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0\[none\]-91\[best performance\]);Mini Mental State Score:to evaluate orientation,
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lecanemab
Study Locations (20)
California
- UCI MIND - Irvine
- University of Southern California - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- Stanford University - Palo Alto
- Sharp Mesa Vista Hospital - San Diego
- University of California, San Francisco - San Francisco
- University of California, Davis - Walnut Creek
Florida
- Advanced Clinical Research Network, Corp - Coral Gables
- Brain Matters Research - Delray Beach
- Mayo Clinic Jacksonville - Jacksonville
- K2 Medical Research - The Villages - Lady Lake
- K2 Medical Research, Llc - Maitland
- Gonzalez MD & Aswad MD Health Sciences - Miami
- Wien Center for Clinical Research - Miami Beach
Arizona
- Banner Alzheimer's Institute - Phoenix
- Banner Sun Health Research Institute - Sun City
District of Columbia
- Georgetown University - Washington D.C.
- Howard University - Washington D.C.
Alabama
- University of Alabama, Birmingham - Birmingham
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2031-01-16 |
| Phase | Phase 3 |
What the registry record for NCT04468659 still lists
NCT04468659 is an interventional study that assigns participants to a tested intervention. Its 1,400 participants enrollment target places it among the larger protocols in the corpus, above the 512-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (173% higher).
The record links to 2 conditions, with Preclinical Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04468659 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04468659 about?
NCT04468659 is a clinical study titled "AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid". The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo ...
What is the current status of trial NCT04468659?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,400 participants. The study started on 2020-07-14. Estimated completion is 2031-01-16.
What conditions does trial NCT04468659 study?
This clinical trial studies the following conditions: Preclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease.
What interventions are being tested in trial NCT04468659?
The interventions under investigation include: Placebo (DRUG), Lecanemab (DRUG).
Who is sponsoring clinical trial NCT04468659?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04468659 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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