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

UnknownPhase 3

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Alzheimer's Disease

Interventions: 3APS

Countries: Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (69)

Antwerp, Belgium
Edegem, Belgium
Leuven, Belgium
Liège, Belgium
Besançon, France
Bordeaux, France
Dijon, France
Lille, France
Marseille, France
Montpellier, France
Nice, France
Paris, France
Reims, France
Rennes, France
Toulouse, France
Tours, France
Berlin, Germany
Frankfurt, Germany
Hamburg, Germany
Heidelberg, Germany
Langendreer, Germany
Leipzig, Germany
Mannheim, Germany
Munich, Germany
Brescia, Italy
Genova, Italy
Modena, Italy
Perugia, Italy
Pisa, Italy
Rome, Italy
+ 39 more on CT.gov