A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT02585934Tipo: INTERVENTIONALInicio: 1 de oct de 2015Fin estimado: 1 de sept de 2017

Traducción no disponible, mostrando original

Resumen

This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.

Descripción detallada

This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Male or female subject with AD
Ongoing donepezil therapy for AD
An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline
Hachinski Ischaemia score less than or equal to 4 at Screening.
If female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.
Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator.
Subject has a reliable caregiver who is willing to report on subject's status throughout the study.

Criterios de exclusión

Other Causes for Dementia
Diagnosis of vascular dementia
Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others.
Confounding Medical Conditions
History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study;
Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Intervenciones

drug

RVT-101

once daily, oral, 35 mg tablets

drug

Placebo

once daily, oral, pill manufactured to match RVT-101 35 mg tablet

Ubicaciones

AR130

La Plata, Buenos Aires, Argentina

AR041

La Plata, Buenos Aires, Argentina

AR101

Buenos Aires, Argentina