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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tramiprosate (3APS)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CL-758017

Identifier Type: -

Identifier Source: org_study_id