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Lecanemab for Alzheimer's Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Alzheimer's Disease+1 MoreLecanemab - Drug
Eligibility
55 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether lecanemab is better than placebo at improving cognition and reducing brain amyloid accumulation in people with Alzheimer's disease.

Eligible Conditions
  • Early-Stage Alzheimer's Disease
  • Alzheimer's Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
LPS
1
Florbetaben
1
[11C]-PIB

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Baseline, Week 96, Week 216

Baseline, Week 216
A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216
A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216
Week 216
A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216
A45 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
LPS
1
Florbetaben
1
[11C]-PIB

Trial Design

4 Treatment Groups

A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg
1 of 4
A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
1 of 4
A3 Trial: Placebo
1 of 4
A45 Trial: Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

1400 Total Participants · 4 Treatment Groups

Primary Treatment: Lecanemab · Has Placebo Group · Phase 3

A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg
Drug
Experimental Group · 1 Intervention: Lecanemab · Intervention Types: Drug
A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
Drug
Experimental Group · 1 Intervention: Lecanemab · Intervention Types: Drug
A3 Trial: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
A45 Trial: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lecanemab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 96, week 216

Who is running the clinical trial?

BiogenIndustry Sponsor
560 Previous Clinical Trials
443,762 Total Patients Enrolled
Eisai Inc.Lead Sponsor
506 Previous Clinical Trials
143,659 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,417 Previous Clinical Trials
3,481,857 Total Patients Enrolled
Alzheimer's Clinical Trials ConsortiumOTHER
3 Previous Clinical Trials
2,270 Total Patients Enrolled

Eligibility Criteria

Age 55 - 80 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a global CDR score of 0 at screening.
The study partner must be willing to participate as a source of information and have approximately weekly contact with the participant
You provide informed consent.

Who else is applying?

What state do they live in?
California30.0%
Illinois20.0%
Ohio10.0%
Other40.0%
How old are they?
65+66.7%
18 - 6533.3%
What site did they apply to?
Hoag Memorial Hospital Presbyterian20.0%
Stanford University20.0%
Univeristy of California, San Francisco20.0%
Other40.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria77.8%
Met criteria22.2%
Why did patients apply to this trial?
  • "I’m hoping to slow the memory loss"
  • "I have been diagnosed with AD and I would like to stop progression if possible"
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. Case Western Reserve University/University Hospitals: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days
References

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