ANAVEX2-73 for Alzheimer's Disease

(ATTENTION-AD Trial)

No longer recruiting at 51 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called ANAVEX2-73, a new potential drug, to help people with Alzheimer's disease by evaluating its safety and effectiveness over time. The goal is to determine if taking this medication daily can improve symptoms or slow their progression. Participants should have completed a previous study with ANAVEX2-73 and have someone who knows them well spend at least 10 hours a week with them to assist with assessments. As a Phase 2 and Phase 3 trial, this study evaluates the treatment's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that ANAVEX2-73 is likely to be safe for humans?

Research has shown that ANAVEX2-73 is generally safe for people. Most side effects (96%) were mild or moderate, and patients recovered after experiencing them. Importantly, no serious brain scan-related side effects were linked to ANAVEX2-73. This suggests it is well-tolerated for treating Alzheimer's disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

ANAVEX2-73 is unique because it targets Alzheimer's Disease by activating the sigma-1 receptor, which plays a crucial role in cellular stress responses. Unlike standard treatments like donepezil or memantine, which mainly focus on managing symptoms, ANAVEX2-73 aims to modify the disease process itself. Researchers are excited about its potential to improve cognitive function and slow disease progression, offering hope for more effective management of Alzheimer's.

What evidence suggests that ANAVEX2-73 might be an effective treatment for Alzheimer's?

Research shows that ANAVEX2-73, also known as blarcamesine, may help treat Alzheimer's disease. One study found that patients taking blarcamesine experienced a 36.3% slower worsening of symptoms over 48 weeks compared to those not taking the drug. This suggests the medication might slow the progression of Alzheimer's symptoms. Additionally, early studies suggest it might even halt or reverse the disease. Importantly, the treatment is considered safe, with most side effects being mild or moderate. These findings offer hope that ANAVEX2-73 could be an effective treatment for Alzheimer's disease. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39800452/

Results from the ANAVEX2-73-AD-004 Phase IIB/III trial

Plasma Aβ42/40-ratio increased significantly with blarcamesine group vs. placebo, (P = 0.048) and whole brain volume loss was significantly ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2274580724006083

Blarcamesine for the treatment of Early Alzheimer's Disease

Blarcamesine, demonstrating a safety profile with no associated neuroimaging adverse events, significantly slowed clinical progression by 36.3% at 48 weeks ...

3.

anavex.com

anavex.com/post/results-from-anavex-life-sciences-landmark-phase-iib-iii-trial-of-blarcamesine-presented-at-alzheime

Results from Anavex Life Sciences Landmark Phase IIb/III ...

Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03790709

Study Details | NCT03790709 | ANAVEX2-73 for Treatment ...

This is a Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment.

5.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/full/10.1016/j.jalz.2016.07.101

P4‐356: Safety and Efficacy 31 Week Data of Anavex 2‐73 in ...

96% of all adverse events were of mild or moderate severity and all events resolved/recovered. MTD was estimated at 48 mg ANAVEX2-73. Secondary ...