Trial Outcomes & Findings for Alzheimer's Disease Acitretin Medication (NCT NCT01078168)
NCT ID: NCT01078168
Last Updated: 2018-02-05
Results Overview
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
baseline and 4 weeks (visit 3)
Results posted on
2018-02-05
Participant Flow
University Medical Centre of the Johannes Gutenberg University, Mainz, and University Medical Centre, Rostock, May 2010 to January 2013
neuropsychiatric testing, general exclusion of e.g. depression or severe diseases affecting the trial
Participant milestones
| Measure |
Acitretin
oral, 30 mg per day, day 1-28
Acitretin: 30mg per day from Day 1 to Day 28
|
Placebo
oral, day 1-28
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Acitretin
oral, 30 mg per day, day 1-28
Acitretin: 30mg per day from Day 1 to Day 28
|
Placebo
oral, day 1-28
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Alzheimer's Disease Acitretin Medication
Baseline characteristics by cohort
| Measure |
Acitretin
n=11 Participants
oral, 30 mg per day, day 1-28
Acitretin: 30mg per day from Day 1 to Day 28
|
Placebo
n=10 Participants
oral, day 1-28
Placebo: Placebo
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
73 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
69.33 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
MMSE
|
20.4 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
23.9 units on a scale
STANDARD_DEVIATION 4.3 • n=7 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeks (visit 3)Population: 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).
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
Outcome measures
| Measure |
Acitretin
n=10 Participants
oral, 30 mg per day, day 1-28
Acitretin: 30mg per day from Day 1 to Day 28
|
Placebo
n=10 Participants
oral, day 1-28
Placebo: Placebo
|
|---|---|---|
|
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
|
1.251 fold change (Visit 3/background)
Standard Deviation 0.4528
|
0.8741 fold change (Visit 3/background)
Standard Deviation 0.2592
|
Adverse Events
Acitretin
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acitretin
n=11 participants at risk
oral, 30 mg per day, day 1-28
Acitretin: 30mg per day from Day 1 to Day 28
|
Placebo
n=10 participants at risk
oral, day 1-28
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
persistent diarrhea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Acitretin
n=11 participants at risk
oral, 30 mg per day, day 1-28
Acitretin: 30mg per day from Day 1 to Day 28
|
Placebo
n=10 participants at risk
oral, day 1-28
Placebo: Placebo
|
|---|---|---|
|
General disorders
headache
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
migraine
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
syncope
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
light headedness
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
derailment of blood glucose
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
lowered glucose tolerance
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
aggressiveness
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscular pain
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Surgical and medical procedures
cataract surgery
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Surgical and medical procedures
memory defect due to anaesthesia
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
gastroenteritis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
diarrhea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
severe diarrhea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Surgical and medical procedures
post-punctual syndrome
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
exfoliation of callus
|
36.4%
4/11 • Number of events 4
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
dry lips
|
45.5%
5/11 • Number of events 5
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
dry eyes
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
alopecia
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
hypertensive crisis
|
18.2%
2/11 • Number of events 4
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
gingivitis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
pruritus
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
eczema
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
dry skin
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
General disorders
backpain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
dry mouth
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
infection due to insect sting
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
Additional Information
Prof. Dr. Andreas Fellgiebel
Clinic of Psychiatry and Psychotherapy, University Medical Center JGU Mainz
Phone: +49-6131-17-7363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place