Mild to moderate dementia of the Alzheimer's type MedDRA version: 5 Level: High Classification code 10001897
Conditions
Interventions
Product Name: NS 2330
Product Code: NS 2330
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet assigned
CAS Number: 195875-86-6
Current Sponsor code: NS 2330 CI
Concentration unit: mg milligram
Sponsors
Boehringer Ingelheim Pharma Ges mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must have a reliable caregiver (who might be the legal representative) that is in frequent (i.e. 24 hours per week) and/or daily contact with the patient, who will accompany the patient to each visit and who will monitor the administration of prescribed medications. The caregiver will be able to communicate in the language in which the patient is being assessed. 2. Patients are male or female without childbearing potential between 40 and 85 yearsof age. 3. Patients have received continuous treatment with 10 mg donepezil once daily for at least 12 weeks prior to baseline investigation at visit 2. 4. Diagnosis of probable mild to moderate DAT as defined by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) guidelines [7]. 5. Mini-Mental State Examination (MMSE) [6] score of 10-26 and Alzheimer’s Disease Assessment Scale - cognitive subscale (ADAS-cog) [2] score > 12 at screening. 6. Modified Hachinski Scale [8], score = 4. 7. CT or MRI scan available and compatible with DAT within the last 12 months prior to visit 2 (see also exclusion criteria). 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. Dementia secondary to other disorders, for example: neurosyphilis, craniocerebral trauma (CT/MRI), hyperthyroidism, hypothyroidism, vitamin B12 or folic acid deficiency. 2. Neurological disease (other than DAT such as: Lewy body dementia - primary diagnosis, Huntington’s disease, Parkinson’s Disease encephalitis, epilepsy, vascular or multi-infarct dementia, stroke, congenital mental deficiency, or multiple sclerosis) and psychiatric disorders such as schizophrenia, major depression, or mental retardation. 3. Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or in the opinion of the investigator) within the last two years, or a positive urine drug screen for cocaine, heroin, marijuana, benzodiazepines. 4. Previous participation in any NS 2330 study. 5. Use of any investigational drug or procedure within 30 days before randomisation. 6. The following drugs are prohibited for 6 weeks prior to randomisation and for the duration of the trial: o Acetyl cholinesterase inhibitors (galantamine, rivastigmine, tacrine, phenserine). o Anti-depressant drugs. 7. The following drugs are prohibited for 8 weeks prior to randomisation, and for the duration of the trial: o Antipsychotics/neuroleptics (see listing Section 11.3). o Monoamine oxidase inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate safety and tolerability of 0.25, 0.5 and 1.0 mg NS 2330 orally and once daily in comparison to placebo, all given as add-on to 10 mg donepezil, once daily over 14 weeks of treatment, in patients with mild to moderate dementia of Alzheimer’s type (DAT). ;Secondary Objective: A secondary objective is to evaluate the possibility of a pharmacokinetic interaction between NS 2330 and donepezil.;Primary end point(s): No primary endpoints with regard to efficacy are investigated. The statistical analysis of safety data is considered as primary analysis for the trial, and will be based on the following endpoints: incidence of adverse events, and changes from baseline in vital sign measurements, standard laboratory measurements. | — |
Countries
Czech Republic, Hungary, Slovakia
Outcome results
None listed