Addressing Dementia Via Agitation-Centered Evaluation
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - 90 |
| Updated: | 3/30/2019 |
| Start Date: | July 13, 2017 |
| End Date: | September 2019 |
| Contact: | Axsome Clinical Trials |
| Email: | ADVANCE-1@axsome.com |
| Phone: | +1 (212) 332-3241 |
A Randomized, Double-blind, Placebo-controlled 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, randomized, double-blind, placebo-controlled study, to assess the
efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's
disease.
efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's
disease.
Key Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient has dementia predominantly of non-Alzheimer's type.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
We found this trial at
57
sites
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