Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease

NACompletedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Moderate Alzheimer's Disease
Interventions
DRUG

ZT-1

Patients in the ZT-1 treatment group will receive ZT 1-1 mg capsules administered p.o. daily during the first month of treatment, followed by ZT-1 implants (9 mg) administered s.c. during the second month of treatment, followed by ZT-1 implants (12 mg) administered s.c. every 4 weeks during months 3 to 6 of treatment. Patients in the ZT-1 treatment group will receive dummy donepezil capsules during months 2 to 6 of the treatment period.

DRUG

Donepezil

Patients in the donepezil treatment group will receive donepezil 5 mg capsules administered p.o. during the first month of treatment, followed by donepezil 10 mg/day during months 2 to 6 of the treatment period. Patients in the donepezil treatment group will also receive s.c. injections of dummy ZT 1 implants every 4 weeks during months 2 to 6 of the treatment period.

Trial Locations (28)

2077

Hornsby-Kuring-gai Health Service, Hornsby

2217

Southern Neurology, Kogarah

2250

Central Coast Neuroscience Research, East Gosford

3081

Austin Health Repatriation Hospital, West Heidelberg

3101

St George's Hospital, Kew

4032

The Prince Charles Hospital, Chermside

5000

Royal Adelaide Hospital, Adelaide

5011

The Queen Elizabeth Hospital, Woodville

6009

Hollywood Specialist Centre, Nedlands (Perth)

T3C 3P1

Calgary West Medical Centre, Calgary

Unknown

Castledowns Medicentre, Edmonton

T1A 4C2

Saibal Nandy Professional Corporation, Medicine Hat

N6C 5J1

Parkwood Hospital, London

M3B 2W7

Toronto Memory Program, Toronto

M6M 3Z5

Gerontion Research Inc., Toronto

J4V 2J2

Neuro Rive-Sud, Montreal

P.Q. H3T 1E2

Jewish General Hospital, Montreal

V1Y 3G8

The Medical Arts Health Research Group, Kelowna

H4H 1R3

Douglas Hospital Research Center, Montreal

V2A 5C8

The Medical Arts Health Research Group, Penticton

TN61HB

OPMHS, Crowborough

NW1 9DB

Camden and Islington Mental Health Trust, London

G20 0XA

Glasgow Memory Clinic, Glasgow

CF64 2XX

Llandough Hospital, Penarth

M8 5RB

Royal Blackburn Hospital, Blackburn

M85RB

North Manchester General Hospital, Manchester

NE4 6BE

New Castle General Hospital, Newcastle upon Tyne

SO30 3JB

MARC - Moorgreen Hospital, Southampton

Sponsors
All Listed Sponsors
lead

Debiopharm International SA

INDUSTRY