Alzheimer's Disease
Conditions
Keywords
tideglusib, Alzheimer, NP-12, NP031112, ARGO, Noscira
Brief summary
The main purpose of this study is to evaluate the cognitive changes after administration of tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in patients with mild to moderate Alzheimer's disease. After the 26 week core treatment period, the patients may continue in the study under blinded conditions for an optional extension period up to a maximum of 39 additional weeks (total study duration up to 65 weeks), until the last patient in the study has completed the 26 week of treatment.
Detailed description
This double-blind, placebo-controlled, randomized, parallel group study will be conducted at multiple centers in the European Union. Patients with mild to moderate Alzheimer's disease will undergo a screening period, and then they will be randomized to one of these four groups: tideglusib 1000 mg once daily (Q.D.), tideglusib 1000 mg every other day (Q.O.D.), tideglusib 500 mg Q.D., or matching placebo, for a 26-week, double-blind, placebo-controlled treatment period.
Interventions
DRUGtideglusib
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
DRUGPlacebo
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Sponsors
ICON Clinical Research
Noscira SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease. 2. Age of 50 to 85 years. 3. MMSE score 14 to 26. 4. Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose Main
Exclusion criteria
1. Significant psychiatric on medical disease. 2. Any chronic liver disease as indicated by out of range values of ALAT, ASAT or direct bilirubin, clinically relevant hepatic steatosis or other clinical manifestations of liver disease 3. Chronic daily drug intake of excluded concomitant medications. 4. Enrollment in another investigational drug study within 3 months before the baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADAS-Cog+ | 26 weeks | The change from Baseline of the 3 active study medication groups will be compared with the placebo group in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog+) |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Alzheimer's Disease Cooperative Study Unit Activities of Daily Living (ADCS-ADL). | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Mini Mental State Examination (MMSE) | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI) | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS) | 26 weeks |
| Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the European Quality of life Instrument (EQ-5D) | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite) | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence | 26 weeks |
| Exploratory Endpoints (only in a subgroup of patients at predefined sites): Change from Baseline of the 3 active study medication groups will be compared with the placebo group in levels of τ, phospho-τ, and β-amyloid in CSF and change in MRI measures. | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Clinical Global Impression of Change (CGIC) | 26 weeks |
Countries
Belgium, Finland, France, Germany, Spain, United Kingdom
Outcome results
None listed