OLE of Phase 2b/3 Study ANAVEX2-73-AD-004 (ATTENTION-AD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04314934 |
Recruitment Status :
Recruiting
First Posted : March 19, 2020
Last Update Posted : April 6, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: ANAVEX2-73 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 450 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004 |
Actual Study Start Date : | October 10, 2019 |
Estimated Primary Completion Date : | May 2024 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Active
ANAVEX2-73
|
Drug: ANAVEX2-73
Oral capsules
Other Name: Blarcamesine |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 96 weeks ]To continue assessing the safety and tolerability of ANAVEX2-73
- ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 96 weeks ]Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
- ADCS-ADL (Activities of Daily Living) [ Time Frame: 96 weeks ]Change from baseline to week 96 in ability to perform daily activities according to the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study.
- Participants may be either outpatients, or residents of an assisted-living facility.
- Participants must have a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.
- No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- Confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing.
Exclusion Criteria:
- Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
- Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study
- Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-V or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
- Any known hypersensitivity to any of the excipients contained in the study drug formulation.

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): NCT04314934
Contact: Study Director | 844-689-3939 | alz@anavex.com |

Responsible Party: | Anavex Life Sciences Corp. |
ClinicalTrials.gov Identifier: | NCT04314934 |
Other Study ID Numbers: |
ANAVEX2-73-AD-EP-004 |
First Posted: | March 19, 2020 Key Record Dates |
Last Update Posted: | April 6, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |