An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00297414

Collaborator

(none)

1,083

Enrollment

145

Locations

Duration (Months)

7.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Other: No intervention

Detailed Description

The objective of this observational study is to ascertain follow-up vital status data for patients who were randomized (assignment of study medication by chance) and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014 and CR005947). This study is designed to evaluate the imbalance of deaths that were initially recorded in the double-blind (neither physician nor patient knows the treatment that the patient receives) phases of two of these studies. Data will be combined from three sources: the databases of the 3 previous studies, forms from investigators, and data acquired during the present study. Investigator will obtain consent from the patients or their informant for participating in the study. Data on vital status will be obtained either from the patient or informant after obtaining informed consent. If a patient does not provide informed consent, documentation of contact with the patient will suffice as evidence that the patient is alive. If an informant does not provide informed consent or a patient cannot be contacted, medical or death records or death registers will be consulted when necessary to determine if a death occurred. If a patient was found to have died, the investigator records the cause of death, date of death, and the adverse events (unwanted consequence that occurs during the course of the clinical study, but not necessarily because of study medication) leading to death, by a review of medical records, autopsy records, and/or death certificates.

Study Design

Study Type:

Observational

Actual Enrollment :

1083 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Patients with mild cognitive impairment Patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.	Other: No intervention No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

Arm

Intervention/Treatment

Patients with mild cognitive impairment

Patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

Other: No intervention

No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

Outcome Measures

Primary Outcome Measures

To evaluate vital status of patients enrolled in 3 galantamine studies [4 weeks]
Poststudy vital status (living or deceased) of patients who participated in 3 clinical studies with galantamine will be evaluated. Data will be collected as vital status of the patient, date of death, cause of death and adverse events associated with death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients who were randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)

Exclusion Criteria:

Patients not enrolled in above referenced studies

Contacts and Locations

Locations

	City	State	Country
1	Tucson	Arizona	United States
2	Laguna Woods	California	United States
3	Northridge	California	United States
4	Oceanside	California	United States
5	Paramount	California	United States
6	San Diego	California	United States
7	San Francisco	California	United States
8	Hamden	Connecticut	United States
9	Hartford	Connecticut	United States
10	New Haven	Connecticut	United States
11	Fort Lauderdale	Florida	United States
12	Miami	Florida	United States
13	North Miami	Florida	United States
14	Oscala F	Florida	United States
15	Saint Petersburg	Florida	United States
16	St. Petersburg	Florida	United States
17	West Palm Beach	Florida	United States
18	Atlanta	Georgia	United States
19	Chicago	Illinois	United States
20	Paducah	Kentucky	United States
21	Glen Burnie	Maryland	United States
22	Rockville	Maryland	United States
23	Boston	Massachusetts	United States
24	Pittsfield	Massachusetts	United States
25	Farmington Hills	Michigan	United States
26	Kalamazoo	Michigan	United States
27	Clementon	New Jersey	United States
28	Ridgewood	New Jersey	United States
29	Summit	New Jersey	United States
30	Albany	New York	United States
31	Bronx	New York	United States
32	New Hyde Park	New York	United States
33	New York	New York	United States
34	Rochester	New York	United States
35	Staten Island	New York	United States
36	Durham	North Carolina	United States
37	Columbus	Ohio	United States
38	Toledo	Ohio	United States
39	Tulsa	Oklahoma	United States
40	Portland	Oregon	United States
41	Pittsburgh	Pennsylvania	United States
42	E Providence	Rhode Island	United States
43	Providence	Rhode Island	United States
44	Austin	Texas	United States
45	Dallas	Texas	United States
46	Houston	Texas	United States
47	Wichita Falls	Texas	United States
48	Bennington	Vermont	United States
49	Richmond	Virginia	United States
50	Tacoma	Washington	United States
51	Middleton	Wisconsin	United States
52	Buenos Aires		Argentina
53	Cordoba		Argentina
54	Adelaide		Australia
55	Christchurch Nz		Australia
56	Hornsby Streets		Australia
57	Kew		Australia
58	Parkville		Australia
59	Perth		Australia
60	Randwick		Australia
61	Woodville		Australia
62	Graz N/A		Austria
63	Innsbruck		Austria
64	Wien		Austria
65	Aalst		Belgium
66	Antwerpen		Belgium
67	Hasselt		Belgium
68	Jumet		Belgium
69	Leuven		Belgium
70	Liege		Belgium
71	Merksem		Belgium
72	Reet		Belgium
73	Roeselare		Belgium
74	Wilrijk		Belgium
75	Edmonton	Alberta	Canada
76	Vancouver	British Columbia	Canada
77	Moncton	New Brunswick	Canada
78	Saint John	New Brunswick	Canada
79	Halifax	Nova Scotia	Canada
80	Barrie	Ontario	Canada
81	Hamilton	Ontario	Canada
82	Kingston	Ontario	Canada
83	London	Ontario	Canada
84	North York	Ontario	Canada
85	Ottawa	Ontario	Canada
86	Toronto	Ontario	Canada
87	Greenfield Park	Quebec	Canada
88	Pointe-Claire	Quebec	Canada
89	Quebec City	Quebec	Canada
90	Verdun	Quebec	Canada
91	Saskatoon	Saskatchewan	Canada
92	London N/A		Canada
93	Montreal N/A		Canada
94	North York		Canada
95	T2n		Canada
96	Chomutov N/A		Czech Republic
97	Dobrany N/A		Czech Republic
98	Hluboká Nad Vltavou		Czech Republic
99	Kolín 2		Czech Republic
100	Opava		Czech Republic
101	Praha 8 N/A		Czech Republic
102	Rennes Cedex		Czech Republic
103	Usti Nad Labem N/A		Czech Republic
104	Helsinki		Finland
105	Kuopio N/A		Finland
106	Toulouse		France
107	Berlin		Germany
108	Frankfurt Am Main		Germany
109	Mannheim		Germany
110	München		Germany
111	Nürnberg		Germany
112	Ulm		Germany
113	Haifa		Israel
114	Petach Tikya		Israel
115	Ramat Gan		Israel
116	Tel Aviv		Israel
117	'S-Hertogenbosch		Netherlands
118	Alkmaar		Netherlands
119	Amsterdam		Netherlands
120	Breda		Netherlands
121	Maastricht		Netherlands
122	Gdansk		Poland
123	Katowice Poland		Poland
124	Lodz N/A		Poland
125	Mosina Poland		Poland
126	Poznan N/A		Poland
127	Poznan Poland		Poland
128	Warszawa		Poland
129	Barakaldo Vizcaya S/N		Spain
130	Barcelona N/A		Spain
131	Madrid		Spain
132	Terrasa Barcelona N/A		Spain
133	Linköping		Sweden
134	Lund N/A		Sweden
135	Malmö		Sweden
136	Mölndal N/A		Sweden
137	Piteå		Sweden
138	Stockholm		Sweden
139	Umeå		Sweden
140	Bradford		United Kingdom
141	Bristol		United Kingdom
142	Clydebank		United Kingdom
143	New Milton		United Kingdom
144	Southampton		United Kingdom
145	Swindon		United Kingdom

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.