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.
- Conditions
- mild to moderate demetia of the Alzheimer type (DAT)MedDRA version: 7.0Level: LLTClassification code 10001896
- Registration Number
- EUCTR2004-001100-12-HU
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
The population will include men and women, 40 to 85 years old with mild to moderate DAT based on the NINCDS-ADRDA criteria: MMSE 10-26 and a Hachinski score =4. Patients must have steady state conditions under donepezil (i.e. 10 mg once daily for at least 12 weeks), and a caregiver available for at least 24 hours/week.
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
Dementia secondary to other disorders; History of malignancy within the last 3 years; History or diagnosis of symptomatic and unstable/uncontrolled cardiovascular illnesses, liver disease such as cirrhosis, active hepatitis B and C, gastrointestinal disorders, and Renal disease; history of drug dependence or abuse; Known history HIV infection; Bodyweight < 50 kg; Planned elective surgery requiring general anaesthesia; Pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method