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

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00322153

First received: May 3, 2006

Last updated: August 25, 2010

Last verified: August 2010

History of Changes

Results First Received: July 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Dementia of the Alzheimer's Type
Interventions:	Drug: memantine ER Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from May 20, 2005 to April 18th, 2007 at 83 study centers in four countries (23 in Argentina, 11 in Chile, 11 in Mexico, and 38 in the US)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study consisted of 1-2 weeks single-blind placebo treatment followed by 24 weeks double-blind treatment. At the end of single-blind placebo treatment, patients meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo.

Reporting Groups

	Description
Placebo	Matching placebo oral administration once daily for 24 weeks.
Memantine ER	28mg once daily oral administration for 24 weeks.

Participant Flow: Overall Study

	Placebo	Memantine ER
STARTED	335 ^[1]	342 ^[2]
SAFETY POPULATION	335 ^[3]	341 ^[4]
COMPLETED	272	273
NOT COMPLETED	63	69
Adverse Event	21	34
Protocol Violation	6	14
Withdrawal by Subject	18	10
Lack of Efficacy	8	3
Lost to Follow-up	5	4
Withdrawn for other reasons	5	4

[1]	Randomized to placebo
[2]	Randomized to Memantine ER
[3]	Safety population defined as all patients who took at least one dose of double-blind study drug.
[4]	Safety population: one patient was randomized but did not receive double-blind study drug.

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Matching placebo oral administration once daily for 24 weeks.
Memantine ER	28mg once daily oral administration for 24 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Memantine ER	Total
Number of Participants [units: participants]	335	341	676
Age, Customized [units: participants]
<= 64 years	26	34	60
65-74 years	79	85	164
75-84 years	179	176	355
>= 85 years	51	46	97
Age [units: years] Mean ± Standard Deviation	76.8 ± 7.76	76.2 ± 8.35	76.5 ± 8.07
Gender [units: participants]
Female	243	244	487
Male	92	97	189
Region of Enrollment [units: participants]
United States	85	93	178
Argentina	158	153	311
Chile	44	46	90
Mexico	48	49	97

Outcome Measures

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1. Primary:

Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ]

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2. Primary:

Clinician’s Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) [ Time Frame: Week 24 ]

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3. Secondary:

Change From Baseline in the 19-Item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor can review results communications prior to public release & can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info & shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Stephen M Graham, PhD
Organization: Forest Research Institute
phone: 201-427-8156
e-mail: Stephen.Graham@frx.com

No publications provided

Responsible Party:	Stephen M Graham, PhD, Senior Director, Clinical Development, Neurology, Forest Research Institute, a subsidiary of Forest Laboratories, Inc
ClinicalTrials.gov Identifier:	NCT00322153 History of Changes
Other Study ID Numbers:	MEM-MD-50
Study First Received:	May 3, 2006
Results First Received:	July 20, 2010
Last Updated:	August 25, 2010
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Chile: Instituto de Salud Publica de Chile Mexico: Ethics Committee Mexico: Ministry of Health Mexico: Secretaria de Salud

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