ARGO

CompletedPhase 2

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

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

Lead sponsor

Noscira SA

Asset

Tideglusib

Listed sites

Recruiting sites

Enrollment

306

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 14-26•AD symptomatic therapy: stable

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01350362

Org study IDNP031112-10B04

Timeline

Milestones

Study start2011-04 (month precision)

Study first posted2011-05-09estimated

Primary completion2012-07actual (month precision)

Study completion2012-10actual (month precision)

Last update posted2012-10-02estimated

Assets

Drug assets

Tideglusib

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Behavior / neuropsychiatric

Caregiver / quality of life

Other (unclassified)

Function / daily living

Amyloid biomarkers

Safety / tolerability / PK

Other clinical outcomes

Global cognition

2 endpoints

Primary/protocol endpoint

ADAS-Cog+

Time frame:26 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

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

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs

Time frame:26 weeks

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.