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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.
 
ClinicalTrials.gov Identifier: NCT01078168
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by (Responsible Party):
K. Lieb, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE March 1, 2010
First Posted Date  ICMJE March 2, 2010
Results First Submitted Date  ICMJE March 14, 2016
Results First Posted Date  ICMJE February 5, 2018
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE March 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
Difference in CSF APPSα concentration at Visit 3 compared to Baseline [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alzheimer`s Disease Acitretin Medication
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Acitretin
    30mg per day from Day 1 to Day 28
    Other Name: Neotigason, Acicutan
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Acitretin
    oral, 30 mg per day, day 1-28
    Intervention: Drug: Acitretin
  • Placebo Comparator: Placebo
    oral, day 1-28
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2010)
76
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01078168
Other Study ID Numbers  ICMJE ADAM
2009-011881-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K. Lieb, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE K. Lieb
Collaborators  ICMJE Alzheimer Forschungsinitiative e.V. (AFI)
Investigators  ICMJE
Principal Investigator: Andreas Fellgiebel, PD Dr. Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany
PRS Account Johannes Gutenberg University Mainz
Verification Date July 2017

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