Alzheimer`s Disease Acitretin Medication (ADAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078168
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz

March 1, 2010
March 2, 2010
March 14, 2016
February 2, 2018
February 2, 2018
March 2010
January 2013   (Final data collection date for primary outcome measure)
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline [ Time Frame: baseline and 4 weeks (visit 3) ]
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
Difference in CSF APPSα concentration at Visit 3 compared to Baseline [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT01078168 on Archive Site
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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 (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: Acitretin
    30mg per day from Day 1 to Day 28
    Other Name: Neotigason, Acicutan
  • Drug: Placebo
  • Active Comparator: Acitretin
    oral, 30 mg per day, day 1-28
    Intervention: Drug: Acitretin
  • Placebo Comparator: Placebo
    oral, day 1-28
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • mild to moderate AD (NINCDS-ADRDA criteria)
  • Mini-Mental State Examination (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2009-011881-27 ( EudraCT Number )
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K. Lieb, Johannes Gutenberg University Mainz
K. Lieb
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
July 2017

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