Recent Updates
Recently added Catalysts

tideglusib

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Icon Plc|Last Updated: Oct 2, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment306

FDA Designations

No designations recorded

Clinical trial landscape

tideglusib · 1 trial · 1 indication

Phase 2 1
NCT01350362Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease PatientsAlzheimer's Disease
COMPLETED306 Analytics
PHASE2COMPLETED
Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tideglusib 1000 mg Q.D.EXPERIMENTALGroup dosed with 1000 mg once daily for 26 weeks/extension
Tideglusib 1000 mg Q.O.D.EXPERIMENTALGroup dosed with 1000 mg once every other day for 26 weeks/extension
Tideglusib 500 mg Q.D.EXPERIMENTALGroup dosed with 500 mg once daily for 26 weeks/extension
PlaceboPLACEBO_COMPARATOROnce daily administration for 26 weeks/extension

Interventions

NameTypeDescription
tideglusibDRUG1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
PlaceboDRUGPowder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Unlock Study Design Details

Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites6

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 ...

Countries:BelgiumFinlandFranceGermanySpainUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about tideglusib

What is tideglusib used for?

Tideglusib is an investigational small molecule being studied for the treatment of Alzheimer's disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with mild-to-moderate Alzheimer's disease.

Who makes tideglusib?

Tideglusib is being developed by Icon Plc, a company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Alzheimer's disease.

What phase is tideglusib in?

Tideglusib is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 2 clinical trial has been completed to assess its efficacy, safety, and tolerability in patients with mild-to-moderate Alzheimer's disease.

What clinical trials is tideglusib in?

Tideglusib has one completed Phase 2 clinical trial with the identifier NCT01350362. This randomized, double-blind, placebo-controlled study enrolled 306 participants across Belgium, Finland, France, Germany, Spain, and the United Kingdom. The trial evaluated the drug's efficacy, safety, and tolerability in patients with mild-to-moderate Alzheimer's disease.

Is tideglusib FDA approved?

Tideglusib is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alzheimer's disease. The drug has completed a Phase 2 clinical trial, but it has not yet received regulatory approval from the FDA or any other health authority.