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UnknownPhase 3

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

An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease

Asset

Tramiprosate

Listed sites

1

Recruiting sites

-

Enrollment

650

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Long-term safety of Tramiprosate (3APS)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCL-758017
NCT IDNCT00314912

Timeline

Milestones

Study first posted2006-04-17estimated
Study start2006-05 (month precision)
Last update posted2007-07-16estimated

Assets

Drug assets

Tramiprosate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.