Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of 10mg memantine in the treatment of memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia

• Conditions: Subjective memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia; MedDRA version: 12.1Level: LLTClassification code 10003729Term: Attention concentration difficulty

• Registration Number: EUCTR2010-020737-50-GB
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-09
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Written informed consent obtained from the subject,
2. Understanding of study procedures and willingness to abide by all procedures during the course of the study,
3. Age =50 and =80,
4. Subjective worsening of memory, concentration or attention problems for longer than 6 months,
5. Woman of childbearing potential must be using a highly effective method of birth control,
6. Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject,
7.Patient Global Impression Severity” (PGI-S) score of =3,
8. Experience of the memory, concentration or attention problems at least four times per week,
9. MiniCog score of 3 or more
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Memory, concentration or attention problems interfere with basic daily activities, 2. Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia).
3. Epilepsy or history of epileptic fits (inclusion questionnaire,
4. Severe or acute mental illness (depression or anxiety),
5. Significant systemic illness, such as cancer, kidney failure, severe hepatic impairment, uncontrolled diabetes,
6. Heart attack, heart failure, arrhythmia or carotid stenosis within the last 6 months,
7. History of stroke or transient ischaemic attacks within the last 6 months,
8. Diagnosed pulmonary, gastrointestinal, hepatic, endocrine, untreated B12, TSH or folate deficiencies,
9. Sleep apnea,
10. Weight below 40kg or above 100kg,
11. Previous or current treatment with memantine or participation in an investigational study with memantine,
12. Con- current use of medication that could have effects on cognition ( seelist in the protocol, 8.3),
13. Taking any medications that are contra-indicated in combination with memantine(see SmPC),
14. Known or suspected history of alcoholism or drug abuse within the past 2 years, 15. Known hypersensitivity to the IP or reference, or any of their formulation ingredients,
16. Subject who is imprisoned or is lawfully kept in an institution,
17. Employee or direct relative of an employee of the CRO, the study site, or Merz, 18. Participation in a clinical study for an IP within the previous 90 days prior to visit 1,
19. Previous participation in this clinical study
20. Clinically significant laboratory results, which may indicate a cause for cognitive symptoms

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified