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AXS-05 for Alzheimer's Disease (ACCORD Trial)

Phase 3
Waitlist Available
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 weeks
Awards & highlights

ACCORD Trial Summary

This trial is testing a new drug to see if it helps with Alzheimer's-related agitation and is comparing it to a placebo.

Eligible Conditions
  • Alzheimer's Disease
  • Agitation in Dementia
  • Psychomotor Agitation

ACCORD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to relapse of agitation symptoms
Other outcome measures
Types and rates of adverse events

Side effects data

From 2019 Phase 3 trial • 327 Patients • NCT04019704
29%
All Others, occurring in <5% of Subjects
16%
Dizziness
13%
Nausea
8%
Headache
7%
Somnolence
7%
Diarrhea
6%
Dry mouth
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AXS-05

ACCORD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-05Experimental Treatment1 Intervention
Up to 26 weeks in double-blind period
Group II: PlaceboPlacebo Group1 Intervention
Up to 26 weeks in double-blind period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2018
Completed Phase 3
~1390

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
8,014 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for people to enroll in this clinical trial?

"No, the information available on clinicaltrials.gov suggests that this particular trial is not currently looking for new patients. The trial was originally posted on December 31st, 2020 but was last updated on August 24th, 2022. Although this trial has completed recruitment, there are 801 other trials that are still looking for volunteers."

Answered by AI

Could you tell me if the upper age limit for participants is 20 years old?

"The minimum age requirement for patients wanting to enroll in this clinical trial is 65 years old. The age limit for this study is 90 years old."

Answered by AI

If a patient lives in city, are there multiple locations where they can participate in this clinical trial?

"There are 60 active clinical trial sites at the moment, with locations in San Antonio, Woodstock, Kelowna, and many others. If you are interested in enrolling, try to pick a location close to reduce travel time and costs."

Answered by AI

Has AXS-05 received FDA market clearance?

"AXS-05 boasts a safety score of 3. This is attributable to the fact that this is a Phase 3 trial, thus there is a certain amount of evidence affirming its efficacy as well as numerous rounds of data supporting its safety."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
2020. "Assessing Clinical Outcomes in Alzheimer's Disease Agitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04797715.
~42 spots leftby Apr 2025
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