Memantine and Intensive Speech-Language Therapy in Aphasia

Gabinete Berthier y Martínez

Status and phase: Completed; Phase 4

Conditions: Stroke; Aphasia

Treatments: Drug: placebo; Behavioral: constraint-induced language therapy (CIAT); Drug: memantine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00640198

Lundbeck, Spain, S.A.

Gabinete Berthier y Martínez.

M-10830

Details and patient eligibility

About

• Aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. Aphasia can be treated with combination of speech-language therapy and drugs. Conventional speech-language therapy in chronic aphasic subjects is of little help and several drugs have been studied with limited success. Therefore other therapeutic strategies are warranted.
• Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may help the recovery of cognitive deficits, included language, in subjects with vascular dementia. The present study examines the safety profile and efficacy of memantine paired with intensive language therapy in subjects with stroke-related chronic aphasia (more than 1 yr. of evolution).

Full description

• The efficacy of drugs that act on glutamate such as the N-methyl-D-aspartic acid (NMDA) receptor antagonist memantine requires to be explored in this population. The rationale for using memantine in post-stroke aphasia comes from recent studies on vascular dementia. Data extracted from a recent Cochrane review of randomized controlled trials of memantine in different types of dementia (vascular dementia, Alzheimer's disease, mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition (including language), activities of daily living, behavior and global scales as well as in the global impression of change.
• Recovery from aphasia is possible even in severe cases. While speech-language therapy remains as the mainstay treatment of aphasia, its effectiveness has not been conclusively proved. This has motivated the planning of more rational therapies (e.g., constraint-induced language therapy [Pulvermüller et al., 2001; 32: 1621-1626]).
• In addition, the neural correlates of improvement of language function can now be readily detectable with event-related potentials. This is a noninvasive technique that can detect in real time functional brain changes during recovery promoted by the combined action of memantine and constraint-induced language therapy.
• The aim of the present study is to assess the efficacy, safety profile, and functional correlates of memantine paired with massed language therapy in a sample of patients with chronic poststroke aphasia.

Enrollment: 28 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic aphasia of more than one year duration
• Must be able to complete protocol

Exclusion criteria

• Dementia
• Major psychiatric illness
• Severe global aphasia (precludes participation in constraint-induced language therapy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Group 1 Memantine

Active Comparator group

Description:

Patients included in this group will receive memantine alone followed by memantine combined with intensive speech-language therapy.

Treatment:

Drug: memantine

Behavioral: constraint-induced language therapy (CIAT)

Drug: memantine

Group 2

Placebo Comparator group

Description:

Patients included in this group will receive placebo alone followed by memantine combined with intensive speech-language therapy.

Treatment:

Behavioral: constraint-induced language therapy (CIAT)

Drug: placebo