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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 5, 2018
Last Update Posted : February 5, 2018
Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 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
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Acitretin

Arm Intervention/treatment
Active Comparator: Acitretin
oral, 30 mg per day, day 1-28
Drug: Acitretin
30mg per day from Day 1 to Day 28
Other Name: Neotigason, Acicutan

Placebo Comparator: Placebo
oral, day 1-28
Drug: Placebo

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01078168

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Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universität Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
K. Lieb
Alzheimer Forschungsinitiative e.V. (AFI)
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Principal Investigator: Andreas Fellgiebel, PD Dr. Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany
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Responsible Party: K. Lieb, Herr Univ.-Prof. Dr. med. Andreas Fellgiebel, Johannes Gutenberg University Mainz Identifier: NCT01078168    
Other Study ID Numbers: ADAM
2009-011881-27 ( EudraCT Number )
First Posted: March 2, 2010    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: July 2017
Keywords provided by K. Lieb, Johannes Gutenberg University Mainz:
Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Keratolytic Agents
Dermatologic Agents