Alzheimer`s Disease Acitretin Medication - Tabular View

Tracking Information

First Received Date ^ICMJE

March 1, 2010

Last Updated Date

September 14, 2010

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference in CSF APPSα concentration at Visit 3 compared to Baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01078168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Alzheimer`s Disease Acitretin Medication

Official Title ^ICMJE

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

Brief Summary

The trials investigates the changes of cerebral spinal fluid APPSα levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease.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

Study Type ^ICMJE

Interventional

Study Phase

Phase II

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

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

Other Name: Vareniclin (Champix)
Drug: Placebo
Placebo

Other Name: Placebo

Study Arms

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

mild to moderate AD (NINCDS-ADRDA criteria)
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Markus Dr. Lorscheider, Clinical coordinator	+49-6131-17-6103	lorscheider@psychiatrie.klinik.uni-mainz.de
Contact: Andreas PD Dr. Fellgiebel, Coordinating investigator	+49-6131-17-2525	fellgiebel@psychiatrie.klinik.uni-mainz.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01078168

Other Study ID Numbers ^ICMJE

ADAM, 2009-011881-27

Has Data Monitoring Committee

Responsible Party

PD Dr. Andreas Fellgiebel, University Medical Center of the Johannes Gutenberg-University Mainz; Department of Psychiatrie and Psychotherapy

Study Sponsor ^ICMJE

Johannes Gutenberg University Mainz

Collaborators ^ICMJE

Alzheimer Forschungsinitiative e.V. (AFI)

Investigators ^ICMJE

Principal Investigator:

Andreas Fellgiebel, PD Dr.

Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany

Information Provided By

Johannes Gutenberg University Mainz

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP