EFFECT OF MEMANTINE TREATMENT ON BRAIN FUNCTION AND MORPHOLOGICAL STRUCTURE IN PATIENTS WITH MODERATE TO SEVERE PATIENTS WITH ALZHEIMER S DISEASE A STRUCTURAL MR AND FMRI STUDY - ND
- Conditions
- MedDRA version: 8.1Level: LLTClassification code 10009843Term: Cognitive deteriorationModerate to severe Alzheimer s disease
- Registration Number
- EUCTR2005-005859-18-IT
- Lead Sponsor
- FONDAZIONE SANTA LUCIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- age at baseline at least 50 years; - MRI or TC tomography computerized done within 12 months before the recruitment in agree with the NINCDS-ADRDA criteria for probable AD; - AD patients with a MMSE score equal or higher than 10. - Moderate AD subjects in stable therapy with anticholinesterase inhibitors for at least 3 months; - drugs permitted at stable doses for at least 2 weeks before the recruitment antidepressive, anti-inflammatory, antiipertensive, antipsichotics atypical, vitamine E 1200 mg/day , anticoagulants, blue pills, diuretics, ipnotics.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
- patients with B12 or folic acid clinically significative deficits; - patients with other diseases at time of baseline or not pharmacological corrected such as pulmonary, gastrointestinal, nephritic, cardiovascular; - patients with other psychiatric or central nervous system diseases, in excess of those ones necessary to diagnose probable AD; - patients with a score at Hachinski modified scale more than 4 Rosen WG, et al. 1980 .
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