Agitation in Patients With Dementia of the Alzheimer's TypePhase 3ACCORDNCT04797715
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
A Phase 3 study testing AXS-05 in people with Agitation in Patients With Dementia of the Alzheimer's Type and Alzheimer Disease, run by Axsome Therapeutics, Inc. at 63 sites in 2 countries.
Trial summary
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- What is being tested?
- AXS-05
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 63 sitesin 2 countries
- Study dates
- 31 Dec 2020to 21 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
- Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.
Who cannot join
- Patient has dementia predominantly of non-Alzheimer's type.
- Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Trial locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
United States61 sites
Clinical Research Site
Augusta, Georgia, 30912
Clinical Research Site
Austin, Texas, 78737
Clinical Research Site
Bangor, Maine, 04401
Clinical Research Site
Boise, Idaho, 83704
Clinical Research Site
Brooklyn, New York, 11229
Clinical Research Site
Charlotte, North Carolina, 28211
Clinical Research Site
Chesterfield, Missouri, 63005
Clinical Research Site
Chula Vista, California, 91910
Clinical Research Site
Columbus, Georgia, 31909
Clinical Research Site
Coral Springs, Florida, 33067
Clinical Research Site
Cypress, Texas, 77429
Clinical Research Site
Dayton, Ohio, 45459
Clinical Research Site
East Syracuse, New York, 13057
Clinical Research Site
Everett, Washington, 98201
Clinical Research Site
Flint, Michigan, 48532
Clinical Research Site
Hialeah, Florida, 33012
Clinical Research Site
Hickory, North Carolina, 28601
Clinical Research Site
Honolulu, Hawaii, 92103
Clinical Research Site
Houston, Texas, 77074
Clinical Research Site
Imperial, California, 92251
Clinical Research Site
Jenkintown, Pennsylvania, 19046
Clinical Research Site
Kissimmee, Florida, 34741
Clinical Research Site
Lafayette, California, 94549
Clinical Research Site
Lake City, Florida, 32055
Clinical Research Site
Las Vegas, Nevada, 89106
Clinical Research Site
Los Alamitos, California, 90720
Clinical Research Site
Los Angeles, California, 90064
Clinical Research Site
Lowell, Massachusetts, 01852
Clinical Research Site
McKinney, Texas, 75071
Clinical Research Site
Mesquite, Texas, 75149
Clinical Research Site
Miami, Florida, 33155
Clinical Research Site
Miami, Florida, 33175
Clinical Research Site
Miami, Florida, 48532
Clinical Research Site
Miami Lakes, Florida, 33014
Clinical Research Site
Naples, Florida, 34105
Clinical Research Site
New Windsor, New York, 12553
Clinical Research Site
New York, New York, 10036
Clinical Research Site
Oceanside, California, 92056
Clinical Research Site
Ocoee, Florida, 34761
Clinical Research Site
Orlando, Florida, 32807
Clinical Research Site
Orlando, Florida, 32819
Clinical Research Site
Pembroke Pines, Florida, 33024
Clinical Research Site
Pensacola, Florida, 32502
Clinical Research Site
Philadelphia, Pennsylvania, 19104
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
San Diego, California, 92103
Clinical Research Site
Santa Ana, California, 92705
Clinical Research Site
St. Petersburg, Florida, 33709
Clinical Research Site
Sugar Land, Texas, 77479
Clinical Research Site
Sun City, Arizona, 85351
Clinical Research Site
Sunrise, Florida, 33351
Clinical Research Site
Suwanee, Georgia, 30024
Clinical Research Site
Tampa, Florida, 33634
Clinical Research Site
Temecula, California, 92591
Clinical Research Site
Toms River, New Jersey, 08755
Clinical Research Site
Trinity, Florida, 34655
Clinical Research Site
Tucson, Arizona, 85710
Clinical Research Site
Waukesha, Wisconsin, 53188
Clinical Research Site
West Jordan, Utah, 84088
Clinical Research Site
Wichita, Kansas, 67214
Clinical Research Site
Woodstock, Vermont, 05091
Canada2 sites
Clinical Research Site
Kelowna, British Columbia, V1Y 1Z9
Clinical Research Site
Newmarket, Ontario, L3Y G8
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
Read the detailed description
Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Being tested
- AXS-05, Placebo
- Keywords
- AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome, ACCORD
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-05Drug
AXS-05 tablets, taken twice daily
PlaceboDrug
Placebo tablets, taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| AXS-05 | Experimental | Up to 26 weeks in double-blind period Receives: Drug: AXS-05 |
| Placebo | Placebo comparator | Up to 26 weeks in double-blind period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to relapse of agitation symptoms
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start31 Dec 2020
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation in Patients With Dementia of the Alzheimer's TypeStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797715
- Sponsor's protocol ID
- AXS-05-AD-302
- Acronym
- ACCORD
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT04797715
- Acronym / sponsor ID
- ACCORD / AXS-05-AD-302
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Keywords
- AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome, ACCORD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
Detailed description
Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-05 | Experimental | Drug: AXS-05Up to 26 weeks in double-blind period |
| Placebo | Placebo comparator | Drug: PlaceboUp to 26 weeks in double-blind period |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
- Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.
Key exclusion criteria (4 listed)
- Patient has dementia predominantly of non-Alzheimer's type.
- Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXS-05AXS-05 tablets, taken twice daily | Drug | AXS-05 |
| PlaceboPlacebo tablets, taken twice daily | Drug | Placebo |
Primary outcome
Time from randomization to relapse of agitation symptoms
Time frame: up to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-05 in people with Agitation in Patients With Dementia of the Alzheimer's Type and Alzheimer Disease, run by Axsome Therapeutics, Inc. at 63 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to relapse of agitation symptoms (time frame: up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.