Clinical trial NCT01350362: Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 4-arm, 26 Week Parallel-Group Study to Evaluate Efficacy, Safety and Tolerability of 2 Oral Doses and 2 Regimes of Tideglusib vs Placebo in Mild-to-Moderate AD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: tideglusib
Alzheimer
NP-12
NP031112
ARGO
Noscira
Lead sponsor: Noscira SA
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2011-05-09
Enrollment: 306
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: ADAS-Cog+
timeFrame: 26 weeks
Secondary outcomes:
measure: Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs
timeFrame: 26 weeks
measure: 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).
timeFrame: 26 weeks
measure: Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Mini Mental State Examination (MMSE)
timeFrame: 26 weeks
measure: Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test
timeFrame: 26 weeks
measure: Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)
timeFrame: 26 weeks
measure: Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS)
timeFrame: 26 weeks
measure: 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)
timeFrame: 26 weeks
measure: 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)
timeFrame: 26 weeks
measure: Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite)
timeFrame: 26 weeks
measure: Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence
timeFrame: 26 weeks
measure: 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.
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Leuven and 4 additional cities
country: Belgium
city: Turku and 3 additional cities
country: Finland
city: Paris and 10 additional cities
country: France
city: Freiburg and 5 additional cities
country: Germany
city: Madrid and 7 additional cities
country: Spain
city: London and 11 additional cities
country: United Kingdom
Study officials:
affiliation: Noscira SA
name: Teodoro del Ser, PhD
role: STUDY_DIRECTOR
References: