Changes of cerebral spinal fluid APPSa levels under oral therapy with acitretin 30 mg daily in patients with mild to moderate Alzheimer’s disease: a multicenter prospective randomised placebo-controlled parallel-group study.
- Conditions
- Alzheimer’s diseaseMedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2009-011881-27-DE
- Lead Sponsor
- niversity Medical Center of the Johannes Gutenberg-University Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
mild to moderate AD (NINCDS-ADRDA criteria)
MMSE according to Folstein: 27-14 points
Geriatric Depression Scale = 14
age = 50 years
ability of subject to understand character and individual consequences of clinical trial
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38
hereditary cognitive impairment
known history of brain injuries
Insufficient German language skills
actual treatment with other potential disease modifying drugs of AD
multimorbidity or significant organ (esp. liver or renal) dysfunction
evidence of Non-AD neurodegenerative disorder (e.g. Parkinson)
contraindication to acitretin such as osteoporosis, hypoalbuminaemia
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