Agitation in Patients With Dementia of the Alzheimer's Type, Agitation, Psychomotor, Alzheimer Disease
Conditions
Keywords
AD Agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome
Brief summary
The primary objective of this open-label extension trial was to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 or ACCORD-2.
Detailed description
This was a multi-center, open-label extension trial to evaluate the long-term safety of AXS-05 in subjects with Alzheimer's disease (AD) agitation that continued to receive AXS-05 given completion of ADVANCE-2 (AXS-05-AD-304) or ACCORD-2 (AXS-05-AD-303).
Interventions
AXS-05 tablets, taken twice daily
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Completed the treatment period in Study AXS-05-AD-304 or exited from Study AXS-05-AD-303 due to study completion. * Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.
Exclusion criteria
* Caregiver is unwilling or unable, in the opinion of the Investigator, to comply with study instructions. * Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone. * Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. * Initiation of a new medication since enrolling in AXS-05-AD-304 and/or AXS-05-AD-303 which may pose a safety risk when taken concurrently with AXS-05.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-Term Safety | Up to 25 weeks | Incidence of treatment-emergent adverse events following dosing with AXS-05 |
Countries
Puerto Rico, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74.3 years STANDARD_DEVIATION 5.31 |
| Race/Ethnicity, Customized Black or African American | 14 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 124 Participants |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 139 |
| other Total, other adverse events | 16 / 139 |
| serious Total, serious adverse events | 0 / 139 |
Outcome results
None listed