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Trial record 14 of 31 for:    ACITRETIN

Alzheimer`s Disease Acitretin Medication (ADAM)

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alzheimer Disease
Interventions Drug: Acitretin
Drug: Placebo
Enrollment 22
Recruitment Details University Medical Centre of the Johannes Gutenberg University, Mainz, and University Medical Centre, Rostock, May 2010 to January 2013
Pre-assignment Details neuropsychiatric testing, general exclusion of e.g. depression or severe diseases affecting the trial
Arm/Group Title Acitretin Placebo
Hide Arm/Group Description

oral, 30 mg per day, day 1-28

Acitretin: 30mg per day from Day 1 to Day 28

oral, day 1-28

Placebo: Placebo

Period Title: Overall Study
Started 11 11
Completed 11 10
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
Arm/Group Title Acitretin Placebo Total
Hide Arm/Group Description

oral, 30 mg per day, day 1-28

Acitretin: 30mg per day from Day 1 to Day 28

oral, day 1-28

Placebo: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
66.9  (9.6) 73  (3.8) 69.33  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
9
  81.8%
6
  60.0%
15
  71.4%
Male
2
  18.2%
4
  40.0%
6
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 11 participants 10 participants 21 participants
11 10 21
MMSE   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 10 participants 21 participants
20.4  (4.2) 23.9  (4.3) 22.2  (4.5)
[1]
Measure Description: MMSE: Mini-Mental State Examination; can be used to systematically and thoroughly assess mental status; range: 0-30; a score of 23 or lower is indicative of cognitive impairment
1.Primary Outcome
Title Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
Hide Description Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
Time Frame baseline and 4 weeks (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were included with successful punctation at V1 and V3. For one Acitretin-treated patient not punctation at V3 was obtained (resulting n of 10).
Arm/Group Title Acitretin Placebo
Hide Arm/Group Description:

oral, 30 mg per day, day 1-28

Acitretin: 30mg per day from Day 1 to Day 28

oral, day 1-28

Placebo: Placebo

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: fold change (Visit 3/background)
1.251  (0.4528) 0.8741  (0.2592)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acitretin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0347
Comments threshold: p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3769
Confidence Interval (2-Sided) 95%
0.03025 to 0.7235
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acitretin Placebo
Hide Arm/Group Description

oral, 30 mg per day, day 1-28

Acitretin: 30mg per day from Day 1 to Day 28

oral, day 1-28

Placebo: Placebo

All-Cause Mortality
Acitretin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acitretin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/10 (0.00%)    
Gastrointestinal disorders     
persistent diarrhea [1]  1/11 (9.09%)  1 0/10 (0.00%)  0
[1]
diagnostic workup because of persistent diarrhea required hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acitretin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/11 (72.73%)      5/10 (50.00%)    
Blood and lymphatic system disorders     
hypertensive crisis  2/11 (18.18%)  4 0/10 (0.00%)  0
Gastrointestinal disorders     
gastroenteritis  1/11 (9.09%)  1 0/10 (0.00%)  0
diarrhea  1/11 (9.09%)  1 0/10 (0.00%)  0
severe diarrhea  1/11 (9.09%)  1 0/10 (0.00%)  0
General disorders     
headache  0/11 (0.00%)  0 1/10 (10.00%)  1
migraine  0/11 (0.00%)  0 1/10 (10.00%)  1
syncope  0/11 (0.00%)  0 1/10 (10.00%)  1
light headedness  0/11 (0.00%)  0 1/10 (10.00%)  1
derailment of blood glucose  0/11 (0.00%)  0 1/10 (10.00%)  1
lowered glucose tolerance  0/11 (0.00%)  0 1/10 (10.00%)  1
aggressiveness  0/11 (0.00%)  0 1/10 (10.00%)  1
backpain  1/11 (9.09%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
muscular pain  0/11 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
exfoliation of callus  4/11 (36.36%)  4 0/10 (0.00%)  0
dry lips  5/11 (45.45%)  5 0/10 (0.00%)  0
dry eyes  1/11 (9.09%)  1 0/10 (0.00%)  0
alopecia  2/11 (18.18%)  2 0/10 (0.00%)  0
gingivitis  1/11 (9.09%)  1 0/10 (0.00%)  0
pruritus  2/11 (18.18%)  2 0/10 (0.00%)  0
eczema  1/11 (9.09%)  1 0/10 (0.00%)  0
dry skin  1/11 (9.09%)  1 0/10 (0.00%)  0
dry mouth  1/11 (9.09%)  1 0/10 (0.00%)  0
infection due to insect sting  1/11 (9.09%)  1 0/10 (0.00%)  0
Surgical and medical procedures     
cataract surgery  0/11 (0.00%)  0 1/10 (10.00%)  1
memory defect due to anaesthesia  0/11 (0.00%)  0 1/10 (10.00%)  1
post-punctual syndrome  1/11 (9.09%)  1 0/10 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Andreas Fellgiebel
Organization: Clinic of Psychiatry and Psychotherapy, University Medical Center JGU Mainz
Phone: +49-6131-17-7363
EMail: Andreas.Fellgiebel@unimedizin-mainz.de
Layout table for additonal information
Responsible Party: K. Lieb, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01078168     History of Changes
Other Study ID Numbers: ADAM
2009-011881-27 ( EudraCT Number )
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: March 14, 2016
Results First Posted: February 2, 2018
Last Update Posted: February 2, 2018