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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011881-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Alzheimer Forschungsinitiative e.V. (AFI) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acitretin | Active Comparator | oral, 30 mg per day, day 1-28 |
|
| Placebo | Placebo Comparator | oral, day 1-28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acitretin | Drug | 30mg per day from Day 1 to Day 28 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline | Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples. | baseline and 4 weeks (visit 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Fellgiebel, PD Dr. | Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
neuropsychiatric testing, general exclusion of e.g. depression or severe diseases affecting the trial
University Medical Centre of the Johannes Gutenberg University, Mainz, and University Medical Centre, Rostock, May 2010 to January 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Acitretin | oral, 30 mg per day, day 1-28 Acitretin: 30mg per day from Day 1 to Day 28 |
| FG001 | Placebo | oral, day 1-28 Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acitretin | oral, 30 mg per day, day 1-28 Acitretin: 30mg per day from Day 1 to Day 28 |
| BG001 | Placebo | oral, day 1-28 Placebo: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline | Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples. | 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). | Posted | Mean | Standard Deviation | fold change (Visit 3/background) | baseline and 4 weeks (visit 3) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acitretin | oral, 30 mg per day, day 1-28 Acitretin: 30mg per day from Day 1 to Day 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| persistent diarrhea | Gastrointestinal disorders | diagnostic workup because of persistent diarrhea required hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Andreas Fellgiebel | Clinic of Psychiatry and Psychotherapy, University Medical Center JGU Mainz | +49-6131-17-7363 | Andreas.Fellgiebel@unimedizin-mainz.de |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017255 | Acitretin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Placebo | Drug | Placebo |
|
| Universität Rostock | Rostock | 18057 | Germany |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MMSE | 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 | Mean | Standard Deviation | units on a scale |
|
oral, day 1-28
Placebo: Placebo
|
|
|
| 1 |
| 11 |
| 8 |
| 11 |
| EG001 | Placebo | oral, day 1-28 Placebo: Placebo | 0 | 10 | 5 | 10 |
|
| migraine | General disorders |
|
| syncope | General disorders |
|
| light headedness | General disorders |
|
| derailment of blood glucose | General disorders |
|
| lowered glucose tolerance | General disorders |
|
| aggressiveness | General disorders |
|
| muscular pain | Musculoskeletal and connective tissue disorders |
|
| cataract surgery | Surgical and medical procedures |
|
| memory defect due to anaesthesia | Surgical and medical procedures |
|
| gastroenteritis | Gastrointestinal disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| severe diarrhea | Gastrointestinal disorders |
|
| post-punctual syndrome | Surgical and medical procedures |
|
| exfoliation of callus | Skin and subcutaneous tissue disorders |
|
| dry lips | Skin and subcutaneous tissue disorders |
|
| dry eyes | Skin and subcutaneous tissue disorders |
|
| alopecia | Skin and subcutaneous tissue disorders |
|
| hypertensive crisis | Blood and lymphatic system disorders |
|
| gingivitis | Skin and subcutaneous tissue disorders |
|
| pruritus | Skin and subcutaneous tissue disorders |
|
| eczema | Skin and subcutaneous tissue disorders |
|
| dry skin | Skin and subcutaneous tissue disorders |
|
| backpain | General disorders |
|
| dry mouth | Skin and subcutaneous tissue disorders |
|
| infection due to insect sting | Skin and subcutaneous tissue disorders |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |