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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020737-50 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Each subject will receive memantine 10mg tablets once daily |
| |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum der RWTH Aachen | Aachen | 52074 | Germany | |||
| Praxis Dr. Heidenreich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Schulz JB, Acker C, Seitzinger A, Pulte I. Randomized, double-blind, placebo-controlled, multicentre study to investigate memantine in the treatment of memory, concentration, and attention problems (subjective cognitive impairment). Journal of the Neurological Sciences 333 Suppl.1: e332, 2013. doi:10.1016/j.jns.2013.07.1232 |
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| Placebo |
| Drug |
Each subject will receive matching placebo tablets once daily |
|
| 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 |
| Böblingen |
| 71032 |
| Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Praxis Dr. Albrecht | Ellwangen | 73479 | Germany |
| Praxis Dr. Reifschneider | Erbach im Odenwald | 64711 | Germany |
| Klinische Forschung Hannover-Mitte | Hanover | 30159 | Germany |
| ZSL Zentrum für medizinische Studien in Leipzig | Leipzig | 04157 | Germany |
| Klinische Forschung Berlin-Mitte | Mitte | 10117 | Germany |
| Praxis Dr. Pauls | München | 80331 | Germany |
| Praxis Dr. Kühn | Oranienburg | 16515 | Germany |
| Praxis Dr. Krause | Wolfratshausen | 82515 | Germany |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Community Pharmacology Services (CPS) | Glasgow | G20 0XA | United Kingdom |
| Moorgreen Hospital | West End, Southampton | SO30 3JB | United Kingdom |
| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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