Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease

NCT00314912 | Unknown Phase 3

• 1 other identifier: CL-758017
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer's disease.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the long-term safety of Tramiprosate (3APS).

Secondary Outcomes (1)

• To provide additional long-term data on the efficacy of Tramiprosate (3APS).

Interventions

Tramiprosate (3APS) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.
• 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).
• Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
• The patient must be presenting a reasonably good nutritional status.
• Signed inform consent from the patient or legal representative.

You may not qualify if:

• Patients will not be eligible to participate in the study if they meet any of the following criteria:
• The patient participates in another drug trial during the study.
• The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.
• The patient is unable to swallow medication tablets.

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (1)

San Francisco Clinical Research Center

San Francisco, California, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tramiprosate

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: May 1, 2006
• Last Updated: July 16, 2007

Record last verified: 2007-07

Locations

US (1)