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ANAVEX2-73 for Alzheimer's Disease (ATTENTION-AD Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Anavex Life Sciences Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects are not listed here, but participants from the previous study cannot join if they had moderate to severe adverse events possibly related to ANAVEX2-73 that haven't resolved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Secondary study objectives
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
ADCS-ADL (Activities of Daily Living)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
ANAVEX2-73
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ANAVEX2-73
2019
Completed Phase 3
~520
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine. Cholinesterase inhibitors work by inhibiting the enzyme cholinesterase, which breaks down acetylcholine, thereby increasing the levels of acetylcholine in the brain.
This is important because acetylcholine is a neurotransmitter associated with memory and learning, and its levels are typically reduced in AD patients. Memantine, on the other hand, is an NMDA receptor antagonist that helps regulate glutamate activity, preventing excitotoxicity that can lead to neuronal damage.
ANAVEX2-73, a Sigma-1 receptor agonist, is being studied for its potential neuroprotective effects, which may help in modulating cellular stress and improving cognitive function. These treatments are crucial as they aim to alleviate symptoms and potentially slow the progression of AD, thereby improving the quality of life for patients.
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Who is running the clinical trial?
Anavex Life Sciences Corp.Lead Sponsor
12 Previous Clinical Trials
1,252 Total Patients Enrolled
Anavex Australia Pty Ltd.Industry Sponsor
4 Previous Clinical Trials
769 Total Patients Enrolled
Anavex Germany GmbHIndustry Sponsor
4 Previous Clinical Trials
865 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not abused drugs or alcohol in the last two years and will pass a drug test.I live at home or in an assisted-living facility.I have someone who spends at least 10 hours a week with me to help with my study needs.
Research Study Groups:
This trial has the following groups:- Group 1: Active
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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