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

Study Overview
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Brief Summary
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The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

Detailed Description
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Duration of treatment: 18 months 3 treatment arms: Placebo and 2 different doses of active drug.

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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: 3APS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3APS|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Alzheimer's disease