OLE of Phase 2b/3 Study ANAVEX2-73-AD-004 (ATTENTION-AD)

August 9, 2024 updated by: Anavex Life Sciences Corp.

Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Study Director
  • Phone Number: 844-689-3939
  • Email: alz@anavex.com

Study Locations

  • Australia
      • Delmont, Australia
        • Melbourne
      • Malvern, Australia
        • Hammond Health
      • Melbourne E., Australia
        • Melbourne
    • NEW
      • Sydney, NEW, Australia
        • Sydney
    • New South Wales
      • Central Coast, New South Wales, Australia
        • Central Coast Neurosciences Research
      • Hornsby, New South Wales, Australia
        • Hornsby (Northern Sydney Health)
      • Hornsby, New South Wales, Australia
        • Sydney
      • Macquarie Park, New South Wales, Australia
        • KaRa MINDS
      • Macquarie Park, New South Wales, Australia
        • Sydney
      • Sydney, New South Wales, Australia
        • University of Sydney
      • Sydney, New South Wales, Australia
        • Sydney
    • Queensland
      • Gold Coast, Queensland, Australia
        • Gold Coast
    • Quennsland
      • Southport, Quennsland, Australia
        • Gold Coast Memory Disorders Clinic
    • South Australia
      • Adelaide, South Australia, Australia
        • Adelaide
    • Victoria
      • Belmont, Victoria, Australia
        • Melbourne
      • Geelong, Victoria, Australia
        • Geelong Private Medical Centre
      • Glen Iris, Victoria, Australia
        • Delmont Private Hospital
      • Malvern, Victoria, Australia
        • Hammond Care
      • Malvern, Victoria, Australia
        • Melbourne
      • Melbourne, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia
        • Melbourne
      • Melbourne N., Victoria, Australia
        • Melbourne
    • Western Australia
      • Nedlands, Western Australia, Australia
        • McCusker
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Healthy Brain Aging Labs Uni of Calgary
    • Ontario
      • Ottawa, Ontario, Canada
        • Bruyere Continuing Care
      • Peterborough, Ontario, Canada
        • Kawartha Centre
      • Toronto, Ontario, Canada
        • Bay Crest Health Sciences
      • Toronto, Ontario, Canada
        • Toronto Memory Program
  • Germany
      • Berlin, Germany
        • Charité University Medicine
    • Baden-Wuerttemberg
      • Ulm, Baden-Wuerttemberg, Germany
        • University of Ulm, Memory Clinic
    • Bavaria
      • Bayreuth, Bavaria, Germany
        • Bayreuth Clinic, Hohe Warte Hospital
      • München, Bavaria, Germany
        • Technical University of Munich, School of Medicine
    • Hessen
      • Mannheim, Hessen, Germany
        • Central Institute of Mental Health
    • Lower Saxony
      • Goettingen, Lower Saxony, Germany
        • Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany
        • University Hospital, Bonn
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany
        • Clinic for Psychiatry and Psychotherapy
  • Netherlands
      • Amsterdam, Netherlands
        • Brain Research Center
      • Den Bosch, Netherlands
        • Brain Research Center
      • Zwolle, Netherlands
        • Brain Research Center
  • United Kingdom
      • Barnsley, United Kingdom
        • MAC Clinical Research
      • Blackpool, United Kingdom
        • MAC Clinical Research
      • Cannock, United Kingdom
        • MAC Clinical Research
      • Leeds, United Kingdom
        • MAC Clinical Research
      • Liverpool, United Kingdom
        • MAC Clinical Research
      • London, United Kingdom
        • Cognition Health
      • London, United Kingdom
        • Imperial College
      • Manchester, United Kingdom
        • MAC Clinical Research
      • Plymouth, United Kingdom
        • Cognition Health
    • County Teesside
      • Teesside, County Teesside, United Kingdom
        • MAC Clinical Research
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • Glasgow Memory Clinic
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Cognition Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
ANAVEX2-73
Drug: ANAVEX2-73
Oral capsules
Other Names:
  • Blarcamesine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
96 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
96 weeks
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)
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anavex Life Sciences Corp.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anavex Australia Pty Ltd.
Anavex Germany GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANAVEX2-73-AD-EP-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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