Alzheimer’s disease MedDRA version: 14.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Neotigason
Product Name: Neotigason
Pharmaceutical Form: Capsule
INN or Proposed INN: ACITRETIN
CAS Number: 55079839
Current Sponsor code: D05BB
Concentration unit: mg milligram(s)
Concent
Sponsors
University Medical Center of the Johannes Gutenberg-University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: mild to moderate AD (NINCDS-ADRDA criteria) MMSE according to Folstein: 27-14 points Geriatric Depression Scale = 14 age = 50 years ability of subject to understand character and individual consequences of clinical trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the mechanism of action of acitretin in AD patients. The increase of CSF APPSa levels in patients treated with acitretin should indicate the activation of the non-amyloidigenic pathway of APP processing via a-secretase.;Secondary Objective: To assess the plasma and CSF concentrations of acitretin To assess cognitive performance under acitretin therapy To assess the stability in activities of daily living under acitretin therapy To assess the stability of neuropsychiatric symptoms under acitretin therapy To compare the safety and tolerability of 30mg acitretin daily in AD patients To assess the changes in CSF ß-Amyloid concentration ;Primary end point(s): The difference in CSF APPSa concentration at Visit 3 (day 30) compared to Baseline (day 0). ;Timepoint(s) of evaluation of this end point: The difference in CSF APPsa concentration at Visit 3 compared to baseline will be analysed by an analysis of covariance (ANCOVA) with factors baseline CSF APPsa, treatment group and centre. The analysis will be performed on a two-sided level of significance a=0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: All secondary endpoints will be analysed by exploratory methods and descriptive statistics only. ;Secondary end point(s): cognitive performance, defined as CERAD test battery performance activities of daily living, defined as Bayer ADL test scores neuropsychiatric symptoms, defined NPI test scores difference in CSF Abeta concentration at Visit 3 compared to Baseline difference in acitretin plasma concentration at Visit 3 compared to Visit 2 acitretin CSF concentration at Visit 3 safety and tolerability | — |
Countries
Germany
Contacts
Public ContactAndreas Fellgiebel
University Medical Center of the Johannes Gutenberg-University Mainz
Outcome results
None listed