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
Overview
- Phase
- Phase 2
- Intervention
- Acitretin
- Conditions
- Alzheimer Disease
- Sponsor
- K. Lieb
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The 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.
Investigators
K. Lieb
Herr Univ.-Prof. Dr. med. Andreas Fellgiebel
Johannes Gutenberg University Mainz
Eligibility Criteria
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
Arms & Interventions
Acitretin
oral, 30 mg per day, day 1-28
Intervention: Acitretin
Placebo
oral, day 1-28
Intervention: Placebo
Outcomes
Primary Outcomes
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
Time Frame: baseline and 4 weeks (visit 3)
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.