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Alzheimer`s Disease Acitretin Medication (ADAM)

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ClinicalTrials.gov Identifier: NCT01078168
Recruitment Status : Unknown
Verified September 2010 by Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
First Posted : March 2, 2010
Last Update Posted : September 15, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Acitretin Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Acitretin
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Acitretin
    30mg per day from Day 1 to Day 28
    Other Name: Vareniclin (Champix)
    Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Difference in CSF APPSα concentration at Visit 3 compared to Baseline [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078168

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

Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Markus Lorscheider, Dr. med.    +49-6131-17-6103    lorscheider@psychiatrie.klinik.uni-mainz.de   
Principal Investigator: Andresa Fellgiebel, PD Dr. med.         
Sub-Investigator: Markus Lorscheider, Dr. med.         
Sub-Investigator: Anke Thuemler         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Alzheimer Forschungsinitiative e.V. (AFI)
Principal Investigator: Andreas Fellgiebel, PD Dr. Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany
More Information

Responsible Party: PD Dr. Andreas Fellgiebel, University Medical Center of the Johannes Gutenberg-University Mainz; Department of Psychiatrie and Psychotherapy
ClinicalTrials.gov Identifier: NCT01078168     History of Changes
Other Study ID Numbers: ADAM
2009-011881-27 ( EudraCT Number )
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Keywords provided by Johannes Gutenberg University Mainz:
Alzheimer`s Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Keratolytic Agents
Dermatologic Agents