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UnknownPhase 3

European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients

A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

Asset

Tramiprosate

Listed sites

69

Recruiting sites

-

Enrollment

930

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required•AD symptomatic therapy: stable ≥4 months

Primary endpoint

-

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-758010
NCT IDNCT00217763

Timeline

Milestones

Study start2005-09 (month precision)
Study first posted2005-09-22estimated
Study completion2007-12estimated (month precision)
Last update posted2007-12-10estimated

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

RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.

INCLUSION CRITERIA:

Participants must meet the following inclusion criteria to be eligible.

•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 an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
•Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study.
•Fluency (oral and written) in the language in which the standardized tests will be administered.
•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.
•Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease.
•Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
•Previous exposure to 3APS.
•Inability to swallow pills.

Endpoints (0)

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.

No endpoints recorded for this trial.

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.