At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
Acitretin +1 moredrug
Likely dose
Acitretin 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Acitretin and Placebo for Alzheimer Disease. Completed, enrolled 22 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesGermany
CollaboratorsAlzheimer Forschungsinitiative e.V. (AFI)
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionJan 2013
Study CompletionMay 2013
TodayJul 2026
First PostedMar 2, 2010
Enrollment StartMar 1, 2010
Primary CompletionJan 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.3 years ago
Interventions
Acitretindrug
30mg per day from Day 1 to Day 28
Placebodrug
Placebo