Phase 2
Completed N=22
Alzheimer's Disease Acitretin Medication
Source: ClinicalTrials.gov NCT01078168 ↗Enrolled (actual)
22
Serious AEs
4.8%
Results posted
Feb 2018
Primary outcomePrimary: Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline — 1.251; 0.8741 fold change (Visit 3/background) — p=0.0347
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline |
1.251; 0.8741 | 0.0347 sig |
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
Data sourced from ClinicalTrials.gov (NCT01078168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.