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Alzheimer`s Disease Acitretin Medication (ADAM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by:
Johannes Gutenberg University Mainz Identifier:
First received: March 1, 2010
Last updated: September 14, 2010
Last verified: September 2010
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 (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

Resource links provided by NLM:

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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01078168

Contact: Markus Dr. Lorscheider, Clinical coordinator +49-6131-17-6103
Contact: Andreas PD Dr. Fellgiebel, Coordinating investigator +49-6131-17-2525

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   
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 Identifier: NCT01078168     History of Changes
Other Study ID Numbers: ADAM
2009-011881-27 ( EudraCT Number )
Study First Received: March 1, 2010
Last Updated: September 14, 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 processed this record on September 19, 2017