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Alzheimer`s Disease Acitretin Medication (ADAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Johannes Gutenberg University Mainz.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01078168
First received: March 1, 2010
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Alzheimer Disease
 Drug: Acitretin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Johannes Gutenberg University Mainz:

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

Estimated Enrollment: 76
Study Start Date: March 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Acitretin
    30mg per day from Day 1 to Day 28
    Other Name: Vareniclin (Champix)
    Drug: Placebo
    Placebo
    Other Name: Placebo
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078168

Contacts
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

Locations
Germany
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)
Investigators
Principal Investigator: Andreas Fellgiebel, PD Dr. Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany
  More Information

No publications provided

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
Study First Received: March 1, 2010
Last Updated: September 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Acitretin
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013