Subjective memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia MedDRA version: 12.1 Level: LLT Classification code 10003729 Term: Attention concentration difficulty
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the efficacy and safety of 10mg/day memantine in comparison to placebo in the treatment of memory, concentration or attention problems (subjective cognitive impairment) in the absence of dementia.;Secondary Objective: To investigate the efficacy of 10mg memantine in comparison to placebo measured by the CogState computer-based neuropsychological test battery [C-NTB], Everyday Cognition 39 [ECog 39], and Hospital Anxiety and Depression Scale [HADS];Primary end point(s): The primary efficacy endpoint is defined as “Patient Global Impression of Change” (PGI-C) at visit 4. The primary efficacy analysis is the statistical comparison between the placebo group and the memantine group at Visit 4 in the Full Analysis Set [FAS] where missing values will be imputed using the Last observation carried forward [LOCF] approach. The group comparison will be performed by the use of an analysis of covariance (ANCOVA) model, with treatment group, “Patient Global Impression Severity” (PGI-S) at screening, gender, age, education, and pooled center as factors. Additionally a reduced ANCOVA model with treatment group and pooled centers as factors will be used. To consider a possible violation of the assumptions of the non-parametric test a Cochan-Mantel-Haenszel test with modified ridit scores stratified by pooled centers will be performed. Furthermore a responder analysis using a logistic regression model will be performed with treatment group, PGI-S at screening, gender, age, education, and pooled centre as independent variables as well as a reduced responder analysis using treatment group and pooled center as independent variables. Response is defined as any improvement in the Subject Global Assessment of Change. Additionally summary statistics will be provided for raw values and the change to Visit 4. Sensitivity analyses of the results will be based on the FAS using observed cases, on the PPS using LOCF and on the | — |
Countries
Germany, United Kingdom
Outcome results
None listed