Title
Alzheimer's Disease Acitretin Medication
Changes of Cerebral Spinal Fluid APPSα 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
Phase
Phase 2Lead Sponsor
Johannes Gutenburg UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Alzheimer DiseaseIntervention/Treatment
acitretin ...Study Participants
22The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD. Second, the safety and tolerability of acitretin in AD patients should be proven.
30mg per day from Day 1 to Day 28
Placebo
Inclusion Criteria: mild to moderate AD (NINCDS-ADRDA criteria) Mini-Mental State Examination (MMSE): 27-14 points Geriatric Depression Scale ≤ 14 Exclusion Criteria: 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
| Event Type | Organ System | Event Term | Acitretin | Placebo |
|---|
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
