Alzheimer's DiseasePhase 2ARGONCT01350362
Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
A Phase 2 study testing tideglusib in people with Alzheimer's Disease, run by Noscira SA at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- tideglusib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Apr 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- tideglusib, Placebo
- Keywords
- tideglusib, Alzheimer, NP-12, NP031112, ARGO, Noscira
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tideglusibDrug
Also called NP-12, NP031112
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
tideglusibDrug
Also called NP-12, NP031112
1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
tideglusibDrug
Also called NP-12, NP031112
500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
PlaceboDrug
Also called NP-12, NP031112
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
| Study group | Role | What they receive |
|---|---|---|
| Tideglusib 1000 mg Q.D. | Experimental | Group dosed with 1000 mg once daily for 26 weeks/extension Receives: Drug: tideglusib |
| Tideglusib 1000 mg Q.O.D. | Experimental | Group dosed with 1000 mg once every other day for 26 weeks/extension Receives: Drug: tideglusib |
| Tideglusib 500 mg Q.D. | Experimental | Group dosed with 500 mg once daily for 26 weeks/extension Receives: Drug: tideglusib |
| Placebo | Placebo comparator | Once daily administration for 26 weeks/extension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+)
Measured: 26 weeks
Secondary outcomes (11)
Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs
Measured: 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).
Measured: 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)
Measured: 26 weeks
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test
Measured: 26 weeks
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)
Measured: 26 weeks
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS)
Measured: 26 weeks
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)
Measured: 26 weeks
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)
Measured: 26 weeks
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite)
Measured: 26 weeks
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence
Measured: 26 weeks
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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noscira SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Teodoro del Ser, PhD, Study director, Noscira SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350362
- Sponsor's protocol ID
- NP031112-10B04
- Acronym
- ARGO
- Status last verified
- Oct 2012
- First submitted
- 6 May 2011
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01350362
- Acronym / sponsor ID
- ARGO / NP031112-10B04
- Conditions
- Alzheimer's Disease
- Keywords
- tideglusib, Alzheimer, NP-12, NP031112, ARGO, Noscira
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Noscira SAIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tideglusib 1000 mg Q.D. | Experimental | Drug: tideglusibGroup dosed with 1000 mg once daily for 26 weeks/extension |
| Tideglusib 1000 mg Q.O.D. | Experimental | Drug: tideglusibGroup dosed with 1000 mg once every other day for 26 weeks/extension |
| Tideglusib 500 mg Q.D. | Experimental | Drug: tideglusibGroup dosed with 500 mg once daily for 26 weeks/extension |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily administration for 26 weeks/extension |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tideglusibAlso: NP-12, NP0311121000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. | Drug | Tideglusib 1000 mg Q.D. |
| tideglusibAlso: NP-12, NP0311121000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension | Drug | Tideglusib 1000 mg Q.O.D. |
| tideglusibAlso: NP-12, NP031112500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. | Drug | Tideglusib 500 mg Q.D. |
| PlaceboAlso: NP-12, NP031112Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension. | Drug | Placebo |
Primary outcome
ADAS-Cog+
Time frame: 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+)
11 secondary outcomes
Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs
Time frame: 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).
Time frame: 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)
Time frame: 26 weeks
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 of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)
Time frame: 26 weeks
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 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 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 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 of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence
Time frame: 26 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teodoro del Ser, PhD study director
Noscira SA
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tideglusib in people with Alzheimer's Disease, run by Noscira SA at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Finland, France, Germany, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog+ (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.