ANAVEX2-73 for Alzheimer's Disease

(ATTENTION-AD Trial)

Recruiting at 49 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Anavex Life Sciences Corp.

Must not be taking: Tricyclic antidepressants

Disqualifiers: Unresolved adverse events, Drug addiction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

300 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take tricyclic antidepressants during the trial.

What makes the drug ANAVEX2-73 unique for treating Alzheimer's disease?

ANAVEX2-73 is unique because it targets sigma-1 receptors, which are involved in cellular stress response and neuroprotection, potentially offering a novel approach to treating Alzheimer's disease compared to traditional treatments that primarily focus on amyloid-beta reduction. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a medication called ANAVEX2-73 to see if it is safe and effective. It targets patients who may need new or better treatment options. The study aims to find out if taking this medication regularly can help improve their condition.

Eligibility Criteria

This trial is for those who completed the ANAVEX2-73-AD-004 study, can be outpatients or in assisted living, and have a partner to help with assessments. They must not have severe suicidal thoughts or behaviors recently and women of childbearing age must not be pregnant.

Inclusion Criteria

Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study

I live at home or in an assisted-living facility.

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)

Exclusion Criteria

I have not abused drugs or alcohol in the last two years and will pass a drug test.

Any known hypersensitivity to any of the excipients contained in the study drug formulation

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily treatment with ANAVEX2-73 to evaluate safety and efficacy

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive ANAVEX2-73 to assess long-term safety and efficacy

Long-term

Treatment Details

Interventions

• ANAVEX2-73

Trial Overview The trial tests the long-term safety and effectiveness of ANAVEX2-73 when taken daily by people with Alzheimer's Disease who participated in a prior related study.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

ANAVEX2-73

Who Is Running the Clinical Trial?

Anavex Life Sciences Corp.

Lead Sponsor

Trials

13

Recruited

1,600+

Anavex Australia Pty Ltd.

Industry Sponsor

Trials

5

Recruited

1,100+

Anavex Germany GmbH

Industry Sponsor

Trials

5

Recruited

1,200+

References

1. United States pubmed.ncbi.nlm.nih.gov

AAV2/1 CD74 Gene Transfer Reduces β-amyloidosis and Improves Learning and Memory in a Mouse Model of Alzheimer's Disease. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cooperative therapeutic action of retinoic acid receptor and retinoid x receptor agonists in a mouse model of Alzheimer's disease. [2014]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Anatabine lowers Alzheimer's Aβ production in vitro and in vivo. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of edaravone on amyloid-β precursor protein processing in SY5Y-APP695 cells. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

New hope from an old drug: fighting Alzheimer's disease with the cancer drug bexarotene (targretin)? [2018]