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Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients (ARGO)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tideglusib
tideglusib
tideglusib
Placebo
Sponsored by
Noscira SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring tideglusib, Alzheimer, NP-12, NP031112, ARGO, Noscira

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tideglusib 1000 mg Q.D.

Tideglusib 1000 mg Q.O.D.

Tideglusib 500 mg Q.D.

Placebo

Arm Description

Group dosed with 1000 mg once daily for 26 weeks/extension

Group dosed with 1000 mg once every other day for 26 weeks/extension

Group dosed with 500 mg once daily for 26 weeks/extension

Once daily administration for 26 weeks/extension

Outcomes

Primary Outcome Measures

ADAS-Cog+
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
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).
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Mini Mental State Examination (MMSE)
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS)
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)
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)
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite)
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence
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.

Full Information

First Posted
May 6, 2011
Last Updated
October 1, 2012
Sponsor
Noscira SA
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01350362
Brief Title
Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
Acronym
ARGO
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noscira SA
Collaborators
ICON Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
tideglusib, Alzheimer, NP-12, NP031112, ARGO, Noscira

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tideglusib 1000 mg Q.D.
Arm Type
Experimental
Arm Description
Group dosed with 1000 mg once daily for 26 weeks/extension
Arm Title
Tideglusib 1000 mg Q.O.D.
Arm Type
Experimental
Arm Description
Group dosed with 1000 mg once every other day for 26 weeks/extension
Arm Title
Tideglusib 500 mg Q.D.
Arm Type
Experimental
Arm Description
Group dosed with 500 mg once daily for 26 weeks/extension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily administration for 26 weeks/extension
Intervention Type
Drug
Intervention Name(s)
tideglusib
Other Intervention Name(s)
NP-12, NP031112
Intervention Description
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
Intervention Type
Drug
Intervention Name(s)
tideglusib
Other Intervention Name(s)
NP-12, NP031112
Intervention Description
1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
Intervention Type
Drug
Intervention Name(s)
tideglusib
Other Intervention Name(s)
NP-12, NP031112
Intervention Description
500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NP-12, NP031112
Intervention Description
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Primary Outcome Measure Information:
Title
ADAS-Cog+
Description
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+)
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs
Time Frame
26 weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teodoro del Ser, PhD
Organizational Affiliation
Noscira SA
Official's Role
Study Director
Facility Information:
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

12. IPD Sharing Statement

Learn more about this trial

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

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