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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of 10mg Memantine in the Treatment of Memory, Concentration or Attention Problems in the Absence of Dementia

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

Intervention / Treatment
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* Drug: Memantine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine<br> | Drug: Memantine<br>* Each subject will receive memantine 10mg tablets once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Each subject will receive matching placebo tablets once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change (PGI-C) at visit 4 | It is the statistical comparison between the placebo group and the memantine group.The group comparison will be performed by the use of an analysis of covariance (ANCOVA) model. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C) |  | 16 weeks | 
| Change from baseline to visit 4 in Everyday Cognition 39 (ECog 39) total score |  | 12 weeks | 
| Change from baseline to visit 4 in Hospital Anxiety and Depression Scale (HADS) Score |  | 12 weeks | 
| Change from baseline to visit 3, 4, 5 of Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd. |  | 16 weeks |