The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease

Sponsor

Forest Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT00090116

Collaborator

(none)

400

Enrollment

Locations

Duration (Months)

11.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Neramexane	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind,Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane Monotherapy in Patients With Moderate to Severe Dementia of the Alzheimer's Type

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of moderate to severe Alzheimer's disease;
ambulatory patients

Exclusion Criteria:

folate deficiency;
clinically significant central nervous system disease other than Alzheimer's disease;
clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pivotal Research Centers	Peoria	Arizona	United States	85381
2	21st Century Neurology	Phoenix	Arizona	United States	85013
3	Margolin Brain Institute	Fresno	California	United States	93720
4	Pharmacology Research Institute	Northridge	California	United States	91324
5	UCI Medical Center	Orange	California	United States	92868
6	Pacific Research Network	San Diego	California	United States	92103
7	Affiliated Research Institute	San Diego	California	United States	92108
8	University of Colorado Health Sciences Center	Denver	Colorado	United States	80262
9	Yale University School of Medicine	New Haven	Connecticut	United States	06510
10	Baumel-Eisner Neuromedical Institute	Fort Lauderdale	Florida	United States	33321
11	Baumel-Eisner Neuromedical Institute	Ft. Lauderdale	Florida	United States	33321
12	Berma Research Group	Hialeah	Florida	United States	33016
13	Palm Beach Neurological Center	Palm Beach Gardens	Florida	United States	33410
14	Neurology Clinical Research, Inc.	Plantation	Florida	United States	33324
15	University of South Florida	Tampa	Florida	United States	33612
16	Palm Beach Neurology	West Palm Beach	Florida	United States	33407
17	Indiana Universisty Medical Center	Indianapolis	Indiana	United States	46202
18	Lexington Clinic	Lexington	Kentucky	United States	40504
19	J. Gary Booker, MD	Shreveport	Louisiana	United States	71101
20	Mood and Memory Clinic of Michigan	Farmington Hills,	Michigan	United States	48334
21	St. Louis University	St. Louis	Missouri	United States	63104
22	Alzheimer's Research Corporation	Lakehurst	New Jersey	United States	08733
23	Joel Ross, MD	Long Branch	New Jersey	United States	07740
24	Ubhc/Umdnj	Piscataway	New Jersey	United States	08855
25	Upstate Clinical Research	Albany	New York	United States	12205
26	Nathan S. Kline Institute for Psychiatric Research	Orangeburg	New York	United States	10962
27	Monroe Community Hospital	Rochester	New York	United States	14620
28	Behavioral Medical Research of Saten Island, PC	Staten Island	New York	United States	10305
29	Piedmont Medical Research	Winston Salem	North Carolina	United States	27103
30	Ohio State University	Columbus	Ohio	United States	443210
31	Neurology and Neuroscience Center of Ohio	Toledo	Ohio	United States	43623
32	Summit Research Network	Portland	Oregon	United States	97223
33	Medical University of South Carolina	Charleston	South Carolina	United States	29406
34	North Texas Neurology Research	Wichita	Texas	United States	76301
35	Pioneer Pharmaceutical Research	Midvale	Utah	United States	84047