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Tramiprosate for Alzheimer's Disease
Phase 3
Waitlist Available
Research Sponsored by Bellus Health Inc. - a GSK company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study the long-term safety of Tramiprosate in patients with Alzheimer's disease.
Who is the study for?
This trial is for adults aged 50 or older with mild to moderate Alzheimer's who completed a previous 78-week study. They must live in the community (or assisted living with supervision) and have a reliable caregiver, be able to swallow tablets, and not be part of another drug trial.Check my eligibility
What is being tested?
The study is testing the long-term safety of Tramiprosate (3APS), previously studied in a Phase III trial, for patients with mild to moderate Alzheimer's disease. It's an open-label extension which means everyone gets the active drug and knows what they are receiving.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with Alzheimer’s treatments may include nausea, diarrhea, insomnia, muscle cramps, fatigue. Participants will be monitored for any long-term safety concerns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 50 and cannot have children (either through surgery or menopause).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the long-term safety of Tramiprosate (3APS).
Secondary outcome measures
To provide additional long-term data on the efficacy of Tramiprosate (3APS).
Find a Location
Who is running the clinical trial?
Bellus Health Inc. - a GSK companyLead Sponsor
17 Previous Clinical Trials
4,688 Total Patients Enrolled
Bellus Health IncLead Sponsor
15 Previous Clinical Trials
4,622 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious or uncontrolled medical condition.I live at home or in assisted living with a caregiver who can help me.I cannot swallow medication tablets.I am over 50 and cannot have children (either through surgery or menopause).
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots in this trial for new patients?
"No, this study is not recruiting patients right now, however, there are 551 other trials that are. This particular trial was first posted on May 1st, 2006 and last updated on July 13th, 2007 according to the information available on clinicaltrials.gov."
Answered by AI
Has this medication been deemed safe by the FDA?
"This treatment option was deemed safe by our team, as it is a Phase 3 trial. This means that not only is there data supporting its efficacy, but also that there have been multiple rounds of data supporting its safety."
Answered by AI
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