search
Back to results

A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

Primary Purpose

Dementia of the Alzheimer's Type

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
memantine ER
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia of the Alzheimer's Type focused on measuring memantine, Alzheimer's disease, moderate to severe Alzheimer's disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ambulatory patients aged >/= 50 years Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months. Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2) Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study. Exclusion Criteria: Patients with a modified Hachinski Ischemia Score greater than 4 at Screening. Patients who have taken memantine within one month of Screening (Visit 1) Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine. Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study. Patients who are receiving therapy with more than one AChEI. Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease. Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder. Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months. Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years Patients who had dementia that was complicated by other organic disease Patients who had dementia complicated by the presence of predominant delusions

Sites / Locations

  • Forest Investigative Site 010
  • Forest Investigative Site 062
  • Forest Investigative Site 050
  • Forest Investigative Site 024
  • Forest Investigative Site 071
  • Forest Investigative Site 002
  • Forest Investigative Site 021
  • Forest Investigative Site 052
  • Forest Investigative Site 070
  • Forest Investigative Site 065
  • Forest Investigative Site 043
  • Forest Investigative Site 044
  • Forest Investigative Site 001
  • Forest Investigative Site 034
  • Forest Investigative Site 068
  • Forest Investigative Site 038
  • Forest Investigative Site 008
  • Forest Investigative Site 028
  • Forest Investigative Site 009
  • Forest Investigative Site 069
  • Forest Investigative Site 045
  • Forest Investigative Site 014
  • Forest Investigative Site 064
  • Forest Investigative Site 011
  • Forest Investigative Site 003
  • Forest Investigative Site 048
  • Forest Investigative Site 006
  • Forest Investigative Site 004
  • Forest Investigative Site 027
  • Forest Investigative Site 012
  • Forest Investigative Site 020
  • Forest Investigative Site 032
  • Forest Investigative Site 018
  • Forest Investigative Site 067
  • Forest Investigative Site 041
  • Forest Investigative Site 017
  • Forest Investigative Site 013
  • Forest Investigative Site 026
  • Forest Investigative Site 103
  • Forest Investigative Site 105
  • Forest Investigative Site 123
  • Forest Investigative Site 113
  • Forest Investigative Site 102
  • Forest Investigative Site 118
  • Forest Investigative Site 109
  • Forest Investigative Site 104
  • Forest Investigative Site 108
  • Forest Investigative Site 114
  • Forest Investigative Site 106
  • Forest Investigative Site 119
  • Forest Investigative Site 122
  • Forest Investigative Site 107
  • Forest Investigative Site 111
  • Forest Investigative Site 121
  • Forest Investigative Site 115
  • Forest Investigative Site 116
  • Forest Investigative Site 112
  • Forest Investigative Site 124
  • Forest Investigative Site 110
  • Forest Investigative Site 125
  • Forest Investigative Site 120
  • Forest Investigative Site 308
  • Forest Investigative Site 301
  • Forest Investigative Site 309
  • Forest Investigative Site 303
  • Forest Investigative Site 310
  • Forest Investigative Site 313
  • Forest Investigative Site 305
  • Forest Investigative Site 302
  • Forest Investigative Site 304
  • Forest Investigative Site 312
  • Forest Investigative Site 306
  • Forest Investigative Site 212
  • Forest Investigative Site 202
  • Forest Investigative Site 207
  • Forest Investigative Site 211
  • Forest Investigative Site 205
  • Forest Investigative Site 203
  • Forest Investigative Site 208
  • Forest Investigative Site 204
  • Forest Investigative Site 213
  • Forest Investigative Site 206
  • Forest Investigative Site 210

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Memantine ER

Arm Description

Oral administration, once daily.

28mg, once daily. Oral administration for 24 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."

Secondary Outcome Measures

Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).

Full Information

First Posted
May 3, 2006
Last Updated
August 25, 2010
Sponsor
Forest Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT00322153
Brief Title
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).
Detailed Description
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia of the Alzheimer's Type
Keywords
memantine, Alzheimer's disease, moderate to severe Alzheimer's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
677 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration, once daily.
Arm Title
Memantine ER
Arm Type
Active Comparator
Arm Description
28mg, once daily. Oral administration for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
memantine ER
Other Intervention Name(s)
Namenda XR
Intervention Description
28mg(7mg capsules) once daily and oral administration for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo oral administration once daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Description
The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
Time Frame
Baseline to week 24
Title
Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
Description
The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
Description
The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).
Time Frame
Baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory patients aged >/= 50 years Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months. Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2) Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study. Exclusion Criteria: Patients with a modified Hachinski Ischemia Score greater than 4 at Screening. Patients who have taken memantine within one month of Screening (Visit 1) Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine. Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study. Patients who are receiving therapy with more than one AChEI. Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease. Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder. Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months. Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years Patients who had dementia that was complicated by other organic disease Patients who had dementia complicated by the presence of predominant delusions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Graham, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 010
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Forest Investigative Site 062
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 050
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Forest Investigative Site 024
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Forest Investigative Site 071
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Forest Investigative Site 002
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Forest Investigative Site 021
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Forest Investigative Site 052
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Forest Investigative Site 070
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Forest Investigative Site 065
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 043
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 044
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 001
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Forest Investigative Site 034
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Forest Investigative Site 068
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 038
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Forest Investigative Site 008
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Forest Investigative Site 028
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Forest Investigative Site 009
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Forest Investigative Site 069
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Forest Investigative Site 045
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Forest Investigative Site 014
City
Saint Loius
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Forest Investigative Site 064
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07742
Country
United States
Facility Name
Forest Investigative Site 011
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Forest Investigative Site 003
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Forest Investigative Site 048
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Forest Investigative Site 006
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Forest Investigative Site 004
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Forest Investigative Site 027
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Forest Investigative Site 012
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Forest Investigative Site 020
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 032
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Forest Investigative Site 018
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Forest Investigative Site 067
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Forest Investigative Site 041
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Forest Investigative Site 017
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 013
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Forest Investigative Site 026
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Forest Investigative Site 103
City
Banfield
State/Province
Buenos Aires
ZIP/Postal Code
B1828CKR
Country
Argentina
Facility Name
Forest Investigative Site 105
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AVG
Country
Argentina
Facility Name
Forest Investigative Site 123
City
Lanus
State/Province
Buenos Aires
ZIP/Postal Code
C1824IBR
Country
Argentina
Facility Name
Forest Investigative Site 113
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Forest Investigative Site 102
City
Buenos Aires
ZIP/Postal Code
1419HDN
Country
Argentina
Facility Name
Forest Investigative Site 118
City
Buenos Aires
ZIP/Postal Code
C1062ABF
Country
Argentina
Facility Name
Forest Investigative Site 109
City
Buenos Aires
ZIP/Postal Code
C1117ABE
Country
Argentina
Facility Name
Forest Investigative Site 104
City
Buenos Aires
ZIP/Postal Code
C1122AAJ
Country
Argentina
Facility Name
Forest Investigative Site 108
City
Buenos Aires
ZIP/Postal Code
C1126AAB
Country
Argentina
Facility Name
Forest Investigative Site 114
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Forest Investigative Site 106
City
Buenos Aires
ZIP/Postal Code
C1209AAB
Country
Argentina
Facility Name
Forest Investigative Site 119
City
Buenos Aires
ZIP/Postal Code
C1405CNF
Country
Argentina
Facility Name
Forest Investigative Site 122
City
Buenos Aires
ZIP/Postal Code
C1413FWO
Country
Argentina
Facility Name
Forest Investigative Site 107
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Forest Investigative Site 111
City
Buenos Aires
ZIP/Postal Code
C1425AGP
Country
Argentina
Facility Name
Forest Investigative Site 121
City
Buenos Aires
ZIP/Postal Code
C1425BPK
Country
Argentina
Facility Name
Forest Investigative Site 115
City
Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Forest Investigative Site 116
City
Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Forest Investigative Site 112
City
Cordoba
ZIP/Postal Code
X5000ALB
Country
Argentina
Facility Name
Forest Investigative Site 124
City
Cordoba
ZIP/Postal Code
X5004AOA
Country
Argentina
Facility Name
Forest Investigative Site 110
City
Mendoza
ZIP/Postal Code
M5500HYF
Country
Argentina
Facility Name
Forest Investigative Site 125
City
Mendoza
ZIP/Postal Code
M5504FMI
Country
Argentina
Facility Name
Forest Investigative Site 120
City
Santa Fe
ZIP/Postal Code
S3000FWO
Country
Argentina
Facility Name
Forest Investigative Site 308
City
Coquimbo
State/Province
Elqui
Country
Chile
Facility Name
Forest Investigative Site 301
City
Las Condes
State/Province
Santiago
Country
Chile
Facility Name
Forest Investigative Site 309
City
Las Condes
State/Province
Santiago
Country
Chile
Facility Name
Forest Investigative Site 303
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Forest Investigative Site 310
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Forest Investigative Site 313
City
Recoleta
State/Province
Santiago
Country
Chile
Facility Name
Forest Investigative Site 305
City
San Ramon
State/Province
Santiago
Country
Chile
Facility Name
Forest Investigative Site 302
City
Antofagasta
Country
Chile
Facility Name
Forest Investigative Site 304
City
Santiago
Country
Chile
Facility Name
Forest Investigative Site 312
City
Santiago
Country
Chile
Facility Name
Forest Investigative Site 306
City
Valdivia
Country
Chile
Facility Name
Forest Investigative Site 212
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Forest Investigative Site 202
City
Mexico City
State/Province
Federal District
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Forest Investigative Site 207
City
Mexico City
State/Province
Federal District
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Forest Investigative Site 211
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Forest Investigative Site 205
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44610
Country
Mexico
Facility Name
Forest Investigative Site 203
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Forest Investigative Site 208
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
44610
Country
Mexico
Facility Name
Forest Investigative Site 204
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Forest Investigative Site 213
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80400
Country
Mexico
Facility Name
Forest Investigative Site 206
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Forest Investigative Site 210
City
San Luis Potosi
ZIP/Postal Code
78090
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
29771687
Citation
Grossberg GT, Alva G, Hendrix S, Ellison N, Kane MC, Edwards J. Memantine ER Maintains Patient Response in Moderate to Severe Alzheimer's Disease: Post Hoc Analyses From a Randomized, Controlled, Clinical Trial of Patients Treated With Cholinesterase Inhibitors. Alzheimer Dis Assoc Disord. 2018 Jul-Sep;32(3):173-178. doi: 10.1097/WAD.0000000000000261.
Results Reference
derived

Learn more about this trial

A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

We'll reach out to this number within 24 hrs