Clinical trial NCT01261741: Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Memory Disorder
Retention Disorder, Cognitive
Subjective Cognitive Impairment
Memory, Concentration or Attention Problems
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2010-12-16
Enrollment: 299
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: "Patient Global Impression of Change" (PGI-C) at visit 4
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)
timeFrame: 16 weeks
measure: Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score
timeFrame: 12 weeks
measure: Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score
timeFrame: 12 weeks
measure: Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
city: Berlin-Mitte
country: Germany
facility: Klinische Forschung Berlin-Mitte
city: Böblingen
country: Germany
facility: Praxis Dr. Heidenreich
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Ellwangen
country: Germany
facility: Praxis Dr. Albrecht
city: Erbach
country: Germany
facility: Praxis Dr. Reifschneider
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte
city: Leipzig
country: Germany
facility: ZSL Zentrum für medizinische Studien in Leipzig
city: München
country: Germany
facility: Praxis Dr. Pauls
city: Oranienburg
country: Germany
facility: Praxis Dr. Kühn
city: Wolfratshausen
country: Germany
facility: Praxis Dr. Krause
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Glasgow
country: United Kingdom
facility: Community Pharmacology Services (CPS)
city: West End, Southampton
country: United Kingdom
facility: Moorgreen Hospital
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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