Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00099216

Collaborator

(none)

708

Enrollment

Locations

Duration (Months)

11.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this research study is to evaluate the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.

Condition or Disease	Intervention/Treatment	Phase
Vascular Dementia	Drug: Rivastigmine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

708 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Change in cognition from baseline at week 24 []
Global clinical impression of change from baseline at week 24 []

Secondary Outcome Measures

Change in activities of daily living from baseline at week 24 []
Change in behavioral symptoms from baseline at week 24 []
Change in clinical staging from baseline at week 24 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between the ages of 50 and 85 years old
Have contact with a responsible caregiver 3 or more days per week
Be male or a female who is surgically sterilized or one year post menopausal

Exclusion Criteria:

Current diagnosis of severe or unstable cardiovascular or other diseases
Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Irvine	California	United States	92618
2	San Francisco	California	United States	94109
3	Boynton Beach	Florida	United States	33426
4	Miami Beach	Florida	United States	33140
5	Port Charlotte	Florida	United States
6	Indianapolis	Indiana	United States	46202
7	Des Moines	Iowa	United States	50314
8	St. Louis	Missouri	United States
9	Albuquerque	New Mexico	United States
10	New York	New York	United States	10003
11	Portland	Oregon	United States	97223
12	Allentown	Pennsylvania	United States	18103
13	Greensburg	Pennsylvania	United States	15601
14	Charleston	South Carolina	United States	29406
15	Austin	Texas	United States	78756
16	Houston	Texas	United States	77030
17	Bennington	Vermont	United States	05201
18	Graz		Austria
19	Linz		Austria
20	Wien		Austria
21	Edmonton	Alberta	Canada
22	Ottawa	Ontario	Canada
23	Toronto	Ontario	Canada
24	Montreal	Quebec	Canada
25	Amiens		France
26	Bordeaux		France
27	Lille Cedex		France
28	Marseille		France
29	Montpellier Cedex		France
30	Toulouse		France
31	Tours Cedex		France
32	Bautzen		Germany
33	Berlin		Germany
34	Bochum		Germany
35	Chemnitz		Germany
36	Eisenhuttenstadt		Germany
37	Erlangen		Germany
38	Freiburg		Germany
39	Luedenscheid		Germany
40	Osnabrueck		Germany
41	Ancona		Italy
42	Brescia		Italy
43	Firenze		Italy
44	Perugia		Italy
45	Reggio Emilia		Italy
46	Roma		Italy
47	Vicenza		Italy
48	Moscow		Russian Federation
49	Saint-Petersburg		Russian Federation
50	Barakaldo		Spain
51	Barcelona		Spain
52	Madrid		Spain
53	Pamplona		Spain
54	Saint Cugat del Valles		Spain
55	Basel		Switzerland
56	Lausanne		Switzerland
57	Newcastle Upon Tyne	Newcastle	United Kingdom
58	Swindon	Wiltshire	United Kingdom
59	Bristol		United Kingdom
60	Clydebank		United Kingdom
61	East Sussex		United Kingdom
62	Southampton		United Kingdom
63	St Annes		United Kingdom