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

March 1, 2010
September 14, 2010
March 2010
April 2011   (final data collection date for primary outcome measure)
Difference in CSF APPSα concentration at Visit 3 compared to Baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01078168 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Alzheimer`s Disease Acitretin Medication
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: Acitretin
    30mg per day from Day 1 to Day 28
    Other Name: Vareniclin (Champix)
  • Drug: Placebo
    Placebo
    Other Name: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Germany
 
NCT01078168
ADAM, 2009-011881-27
No
PD Dr. Andreas Fellgiebel, University Medical Center of the Johannes Gutenberg-University Mainz; Department of Psychiatrie and Psychotherapy
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
Johannes Gutenberg University Mainz
September 2010

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