Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems

Merz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Memory, Concentration or Attention Problems; Subjective Cognitive Impairment; Retention Disorder, Cognitive; Memory Disorder

Treatments: Drug: Memantine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01261741

MRZ 90001-2267 / 1

2010-020737-50 (EudraCT Number)

Details and patient eligibility

About

In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia.

Enrollment: 299 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjective worsening of memory, concentration or attention problems for longer than 6 months
• Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject
• Experience of the memory, concentration or attention problems at least four times per week

Exclusion criteria

• Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia)
• Significant systemic illness, such as cancer, heart or kidney failure, uncontrolled diabetes
• History of stroke or seizure, or myocardial infarction within the last year (e.g. by inclusion questionnaire, physician interview)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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299 participants in 2 patient groups, including a placebo group

Memantine

Experimental group

Treatment:

Drug: Memantine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo