Alzheimer`s Disease Acitretin Medication

Alzheimer Disease Clinical Trial

— ADAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078168
• Other study ID #: ADAM
• Secondary ID: 2009-011881-27
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2010
• Last updated: July 18, 2017
• Start date: March 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Acitretin
30mg per day from Day 1 to Day 28
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz	Mainz	Rheinland-Pfalz
Germany	Universität Rostock	Rostock

Sponsors (2)

Lead Sponsor	Collaborator
K. Lieb	Alzheimer Forschungsinitiative e.V. (AFI)

Country where clinical trial is conducted

Germany, 

Outcome

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