Alzheimer's Disease Acitretin Medication

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Placebo; Drug: Acitretin

• Registration Number: NCT01078168
• Lead Sponsor: K. Lieb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Results First Submitted: 2016-03-14
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Results First Posted: 2018-02-05
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	oral, day 1-28
Acitretin	Acitretin	oral, 30 mg per day, day 1-28

Primary Outcome Measures

Name	Time	Method
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline	baseline and 4 weeks (visit 3)	Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.

Trial Locations

Locations (2)

Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Universität Rostock; 🇩🇪 Rostock, Germany