Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)
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ClinicalTrials.gov Identifier: NCT03226522 |
Recruitment Status :
Completed
First Posted : July 21, 2017
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Agitation in Patients With Dementia of the Alzheimer's Type Alzheimer Disease Agitation,Psychomotor | Drug: AXS-05 Drug: Bupropion Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 366 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 13, 2017 |
Actual Primary Completion Date : | April 17, 2020 |
Actual Study Completion Date : | April 17, 2020 |

Arm | Intervention/treatment |
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Experimental: AXS-05
AXS-05 tablets taken by mouth for 5 weeks.
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Drug: AXS-05
AXS-05 |
Active Comparator: Bupropion
Bupropion tablets taken by mouth for 5 weeks.
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Drug: Bupropion
Bupropion |
Placebo Comparator: Placebo
Placebo tablets taken by mouth for 5 weeks.
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Drug: Placebo
Placebo |
- Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 5 weeks ]Change from Baseline to Week 5 in the CMAI

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Ages Eligible for Study: | 65 Years to 90 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226522

Responsible Party: | Axsome Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03226522 |
Other Study ID Numbers: |
AXS-05-AD-301 |
First Posted: | July 21, 2017 Key Record Dates |
Last Update Posted: | October 8, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations |
Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |