A multi-centre, double-blind, parallel-group, randomised, placebo-controlled study to investigate the safety and tolerability of 0.25, 0.5 and 1.0 mg NS 2330 orally and once daily during a 14-week treatment period as add-on to 10 mg donepezil once daily in patients with mild to moderate dementia of the Alzheimer's type. - Not available

Phase 1

• Conditions: Mild to moderate dementia of the Alzheimer's type; MedDRA version: 5Level: HighClassification code 10001897

• Registration Number: EUCTR2004-001100-12-CZ
• Lead Sponsor: Boehringer Ingelheim Pharma Ges mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-06-29
• Study Completion: 2005-03-18
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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

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.

Study & Design

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