Alzheimer DiseasePhase 2/3ATTENTION-ADNCT04314934
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
A Phase 2/3 study testing ANAVEX2-73 in people with Alzheimer Disease, run by Anavex Life Sciences Corp. at 51 sites in 5 countries.
Trial summary
This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- ANAVEX2-73
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 51 sitesin 5 countries
- Study dates
- 10 Oct 2019to 14 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
51 sites in 5 countries.
51 sites in 5 countries
Australia23 sites
Adelaide
Adelaide, South Australia
Melbourne
Belmont, Victoria
Central Coast Neurosciences Research
Central Coast, New South Wales
Melbourne
Delmont
Geelong Private Medical Centre
Geelong, Victoria
Delmont Private Hospital
Glen Iris, Victoria
Gold Coast
Gold Coast, Queensland
Hornsby (Northern Sydney Health)
Hornsby, New South Wales
Sydney
Hornsby, New South Wales
KaRa MINDS
Macquarie Park, New South Wales
Sydney
Macquarie Park, New South Wales
Hammond Care
Malvern, Victoria
Melbourne
Malvern, Victoria
Hammond Health
Malvern
Austin Health
Melbourne, Victoria
Melbourne
Melbourne, Victoria
Melbourne
Melbourne E.
Melbourne
Melbourne N., Victoria
McCusker
Nedlands, Western Australia
Gold Coast Memory Disorders Clinic
Southport, Quennsland
Sydney
Sydney, New South Wales
University of Sydney
Sydney, New South Wales
Sydney
Sydney, NEW
United Kingdom12 sites
MAC Clinical Research
Barnsley
MAC Clinical Research
Blackpool
MAC Clinical Research
Cannock
Glasgow Memory Clinic
Glasgow, Scotland
Cognition Health
Guildford, Surrey
MAC Clinical Research
Leeds
MAC Clinical Research
Liverpool
Cognition Health
London
Imperial College
London
MAC Clinical Research
Manchester
Cognition Health
Plymouth
MAC Clinical Research
Teesside, County Teesside
Germany8 sites
Bayreuth Clinic, Hohe Warte Hospital
Bayreuth, Bavaria
Charite University Medicine
Berlin
University Hospital, Bonn
Bonn, North Rhine-Westphalia
Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy
Göttingen, Lower Saxony
Clinic for Psychiatry and Psychotherapy
Mainz, Rhineland-Palatinate
Central Institute of Mental Health
Mannheim, Hesse
Technical University of Munich, School of Medicine
München, Bavaria
University of Ulm, Memory Clinic
Ulm, Baden-Wurttemberg
Canada5 sites
Healthy Brain Aging Labs Uni of Calgary
Calgary, Alberta
Bruyere Continuing Care
Ottawa, Ontario
Kawartha Centre
Peterborough, Ontario
Bay Crest Health Sciences
Toronto, Ontario
Toronto Memory Program
Toronto, Ontario
Netherlands3 sites
Brain Research Center
's-Hertogenbosch
Brain Research Center
Amsterdam
Brain Research Center
Zwolle
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- ANAVEX2-73
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANAVEX2-73Drug
Also called Blarcamesine
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | ANAVEX2-73 Receives: Drug: ANAVEX2-73 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
To continue assessing the safety and tolerability of ANAVEX2-73
Measured: 96 weeks
Secondary outcomes (2)
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
Measured: 96 weeks
ADCS-ADL (Activities of Daily Living)
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)
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start10 Oct 2019
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anavex Life Sciences Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anavex Australia Pty Ltd., Anavex Germany GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314934
- Sponsor's protocol ID
- ANAVEX2-73-AD-EP-004
- Acronym
- ATTENTION-AD
- Status last verified
- Aug 2024
- First submitted
- 12 Dec 2019
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macfarlane S, Grimmer T, Teo K, O'Brien TJ, Woodward M, Grunfeld J, Mander A, Brodtmann A, Brew BJ, Morris P, Short C, Kurrle S, Lai R, Bharadwaj S, Drysdale P, Sturm J, Lewis SJG, Barton D, Kalafatis C, Sharif S, Perry R, Mannering N, MacSweeney JE, Pearson S, Evans C, Krishna V, Thompson A, Munisamy M, Bhatt N, Asher A, Connell S, Lynch J, Rutgers SM, Dautzenberg PL, Prins N, Oschmann P, Frolich L, Tacik P, Peters O, Wiltfang J, Henri-Bhargava A, Smith E, Pasternak S, Frank A, Chertkow H, Ingram J, Hsiung GR, Brittain R, Tartaglia C, Cohen S, Villa LM, Gordon E, Jubault T, Guizard N, Tucker A, Kaufmann WE, Jin K, Chezem WR, Missling CU, Sabbagh MN. Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial. J Prev Alzheimers Dis. 2025 Jan;12(1):100016. doi: 10.1016/j.tjpad.2024.100016. Epub 2025 Jan 1.
PubMed 39800452
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
- ClinicalTrials.gov ID
- NCT04314934
- Acronym / sponsor ID
- ATTENTION-AD / ANAVEX2-73-AD-EP-004
- Conditions
- Alzheimer Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Anavex Life Sciences Corp.Industry (pharma, biotech, devices)
- Collaborators
- Anavex Australia Pty Ltd., Anavex Germany GmbH
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: ANAVEX2-73ANAVEX2-73 |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANAVEX2-73Also: BlarcamesineOral capsules | Drug | Active |
Primary outcome
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
2 secondary outcomes
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
Time frame: 96 weeks
ADCS-ADL (Activities of Daily Living)
Time frame: 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 39800452Macfarlane S, Grimmer T, Teo K, O'Brien TJ, Woodward M, Grunfeld J, Mander A, Brodtmann A, Brew BJ, Morris P, Short C, Kurrle S, Lai R, Bharadwaj S, Drysdale P, Sturm J, Lewis SJG, Barton D, Kalafatis C, Sharif S, Perry R, Mannering N, MacSweeney JE, Pearson S, Evans C, Krishna V, Thompson A, Munisamy M, Bhatt N, Asher A, Connell S, Lynch J, Rutgers SM, Dautzenberg PL, Prins N, Oschmann P, Frolich L, Tacik P, Peters O, Wiltfang J, Henri-Bhargava A, Smith E, Pasternak S, Frank A, Chertkow H, Ingram J, Hsiung GR, Brittain R, Tartaglia C, Cohen S, Villa LM, Gordon E, Jubault T, Guizard N, Tucker A, Kaufmann WE, Jin K, Chezem WR, Missling CU, Sabbagh MN. Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial. J Prev Alzheimers Dis. 2025 Jan;12(1):100016. doi: 10.1016/j.tjpad.2024.100016. Epub 2025 Jan 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ANAVEX2-73 in people with Alzheimer Disease, run by Anavex Life Sciences Corp. at 51 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Australia, United Kingdom, Germany, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.