Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients - Full Text View

Sponsor:	Noscira SA
Collaborator:	ICON Clinical Research
Information provided by (Responsible Party):	Noscira SA
ClinicalTrials.gov Identifier:	NCT01350362

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: tideglusib Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Noscira SA:

Primary Outcome Measures:

ADAS-Cog+ [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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 Outcome Measures:

Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
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). [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Mini Mental State Examination (MMSE) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	April 2011
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tideglusib 1000 mg Q.D. Group dosed with 1000 mg once daily for 26 weeks/extension	Drug: tideglusib 1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. Other Names: NP-12 NP031112
Experimental: Tideglusib 1000 mg Q.O.D. Group dosed with 1000 mg once every other day for 26 weeks/extension	Drug: tideglusib 1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension Other Names: NP-12 NP031112
Experimental: Tideglusib 500 mg Q.D. Group dosed with 500 mg once daily for 26 weeks/extension	Drug: tideglusib 500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. Other Names: NP-12 NP031112
Placebo Comparator: Placebo Once daily administration for 26 weeks/extension	Drug: Placebo Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension. Other Names: NP-12 NP031112

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

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease.
Age of 50 to 85 years.
MMSE score 14 to 26.
Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose

Main Exclusion Criteria:

Significant psychiatric on medical disease.
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
Chronic daily drug intake of excluded concomitant medications.
Enrollment in another investigational drug study within 3 months before the baseline visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350362

Locations

Belgium

Leuven and 4 additional cities, Belgium
Finland

Turku and 3 additional cities, Finland
France

Paris and 10 additional cities, France
Germany

Freiburg and 5 additional cities, Germany
Spain

Madrid and 7 additional cities, Spain
United Kingdom

London and 11 additional cities, United Kingdom

Sponsors and Collaborators

Noscira SA

ICON Clinical Research

Investigators

Study Director:

Teodoro del Ser, PhD

Noscira SA

More Information

No publications provided

Responsible Party:	Noscira SA
ClinicalTrials.gov Identifier:	NCT01350362 History of Changes
Other Study ID Numbers:	NP031112-10B04
Study First Received:	May 6, 2011
Last Updated:	January 2, 2012
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios France: Afssaps - French Health Products Safety Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Belgium: Federal Agency for Medicinal Products and Health Products Finland: Finnish Medicines Agency

Keywords provided by Noscira SA:

tideglusib
Alzheimer
NP-12

NP031112
ARGO
Noscira

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2012