NCT01350362

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

May 6, 2011

Last Update Submit

October 1, 2012

Conditions

Alzheimer's Disease

Keywords

tideglusibAlzheimerNP-12NP031112ARGONoscira

Outcome Measures

Primary Outcomes (1)

  • 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+)

    26 weeks

Secondary Outcomes (11)

  • 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 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

  • +6 more secondary outcomes

Study Arms (4)

Tideglusib 1000 mg Q.D.

EXPERIMENTAL

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

Drug: tideglusib

Tideglusib 1000 mg Q.O.D.

EXPERIMENTAL

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

Drug: tideglusib

Tideglusib 500 mg Q.D.

EXPERIMENTAL

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

Drug: tideglusib

Placebo

PLACEBO COMPARATOR

Once daily administration for 26 weeks/extension

Drug: Placebo

Interventions

tideglusibDRUG

1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.

Also known as: NP-12, NP031112
Tideglusib 1000 mg Q.D.
PlaceboDRUG

Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.

Also known as: NP-12, NP031112
Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Leuven and 4 Additional Cities, Belgium

Location

Unknown Facility

Turku and 3 Additional Cities, Finland

Location

Unknown Facility

Paris and 10 Additional Cities, France

Location

Unknown Facility

Freiburg and 5 Additional Cities, Germany

Location

Unknown Facility

Madrid and 7 Additional Cities, Spain

Location

Unknown Facility

London and 11 Additional Cities, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tideglusib

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Teodoro del Ser, PhD

    Noscira SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 9, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations

FR(1)FI(1)DE(1)BE(1)ES(1)GB(1)