A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living.

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 12, 2013

Primary Completion Date

September 16, 2016

Study Completion Date

April 21, 2017

Conditions
Down Syndrome
Interventions
DRUG

E2020-Donepezil hydrochloride

3 mg of E2020 (oral) once daily, for 24 weeks

DRUG

E2020-Donepezil hydrochloride

5 mg of E2020 (oral) once daily, for 24 weeks

DRUG

Placebo

placebo (oral) once daily, for 24 weeks

Trial Locations (10)

Unknown

Fukuoka

Sapporo

Yokohama

Takatsuki-shi

Matsumoto-shi

Nagasaki

Izumi-shi

Saitama-shi

Chiyoda-ku

Setagaya-ku

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT02094053 - A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living. | Biotech Hunter | Biotech Hunter