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UnknownPhase 3

Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease

A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer's Disease

Asset

Tramiprosate

Listed sites

67

Recruiting sites

-

Enrollment

950

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Brain volume change from baseline

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-758007
NCT IDNCT00088673

Timeline

Milestones

Study start2004-06 (month precision)
Study first posted2004-08-03estimated
Last update posted2007-02-28estimated

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

Patients may be included in this study if they meet all of the following criteria:

•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).
•Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
•Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
•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.
•Potential participant must be treated with conventional Alzheimer's disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
•Fluency in English, French or Spanish (oral and written).
•Signed informed consent from potential participant or legal representative and caregiver

Exclusion criteria

Patients will not be eligible to participate in the study if they meet any of the following criteria:

•Potential participant with any other cause of dementia.
•Life expectancy less than 2 years.
•Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
•Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
•Previous use of 3APS.

Patient recruitment is done by participating centers.

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

Global cognition
1
Neuroimaging
1

Global cognition

1 endpoint
Primary/protocol endpoint

The two primary efficacy parameters are the change from baseline to month 18 in the Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog) and the clinical Deterioration Scale Sum of Boxes (CDR-SB) scores.

ADAS-Cog

change from baseline, improvement

Neuroimaging

1 endpoint
Primary/protocol endpoint

The brain volume change from baseline as measured by Magnetic Resonance Imaging will also be assessed.

change from baseline, improvement

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.