Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: placebo; Drug: Memantine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469456

MEM-MD-71

Details and patient eligibility

About

The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease

Enrollment: 265 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline

Exclusion criteria

• Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV) Axis I disorder other than AD
• Previous imaging results not consistent with the diagnosis of AD
• Modified Hachinski Ischemia Score greater than 4
• Evidence of other neurologic disorders
• Clinically significant systemic disease
• A known or suspected history of alcohol or drug abuse in the past 5 years
• Taking excluded medication
• Previous treatment with commercial memantine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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265 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Treatment:

Drug: Memantine

2

Placebo Comparator group

Description:

Placebo oral administration twice daily for 12 weeks

Treatment:

Drug: placebo