Alzheimer DiseasePhase 3NCT01872598
Masitinib in Patients With Mild to Moderate Alzheimer's Disease
A Phase 3 study testing Masitinib in people with Alzheimer Disease, run by AB Science at 6 sites in 6 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Masitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 721 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jan 2012to Dec 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with dementia of Alzheimer's type, according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
- Patient with probable Alzheimer' disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA)
- Patient with MMSE ≥ 12 and ≤ 25 at baseline
- Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline, and/or a stable dose of memantine for a minimum of 6 months at baseline, with no changes foreseen in therapy throughout the study.
Who cannot join
- Patient with any other cause of dementia not due to Alzheimer's disease.
- Patient with Alzheimer disease with severe forms of delusions or delirium (patients with light and mild forms of delusions and delirium will be allowed in the study).
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Ukraine1 site
Municipal Institution Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov
Dnipropetrovsk, 49005
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease
The purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine.
Read the detailed description
Actual standard treatment for mild to moderately severe Alzheimer's dementia includes acetylcholinesterase inhibitors (donepezil, rivastigmine and galantamine) and a NMDA receptor antagonist (memantine for moderate to severe Alzheimer's disease). These medications have shown to have an effect on some cognitive and non cognitive symptoms of the pathology. However, their efficacy remains limited and may decrease with time. There is an unmet medical need in this pathology. Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes, as well as possibly disruption of the Aβ signaling cascade via inhibition of the Fyn signaling pathway. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of oral masitinib. The objective of this study is to compare the efficacy and safety of masitinib at various doses versus matched placebo in the treatment of patients with mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine. Approximately 675 patients will be randomized into 5 treatment groups. The co-primary outcome measures are the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL), and Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog) after 24 weeks of treatment.
- Conditions
- Alzheimer Disease
- Being tested
- Masitinib, Placebo, Standard of care
- Keywords
- Alzheimer, dementia, cognitive disease, memory loss, cerebrovascular disease, tyrosine kinase inhibitor
- Medical subject headings
- Alzheimer Disease, Dementia, Cognition Disorders, Memory Disorders, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasitinibDrug
Also called AB1010
PlaceboDrug
Also called Placebo Oral Tablet
Standard of careDrug
stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine, as per standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Masitinib escalating dose | Experimental | Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment Receives: Drug: Masitinib; Drug: Standard of care |
| Masitinib fixed dose (4.5 mg/kg/day) | Experimental | Participants receive masitinib at 4.5 mg/kg/day, given orally twice daily. Receives: Drug: Masitinib; Drug: Standard of care |
| Masitinib fixed dose (3.0 mg/kg/day) | Experimental | Participants receive masitinib at 3.0 mg/kg/day, given orally twice daily. Receives: Drug: Masitinib; Drug: Standard of care |
| Placebo (escalating dose) | Placebo comparator | Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment Receives: Drug: Placebo; Drug: Standard of care |
| Placebo (fixed dose) | Placebo comparator | Participants receive fixed dose placebo, given orally twice daily Receives: Drug: Placebo; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADCS-ADL
Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL).
Measured: 24 weeks
ADAS-Cog
Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog).
Measured: 24 weeks
Secondary outcomes (2)
MMSE
Change in Mini Mental State Examination (MMSE)
Measured: 24 weeks
CIBIC-plus
Clinician's Interview Based Impression of Change-plus (CIBIC-plus)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno DUBOIS, M.D., Ph.D., Principal investigator, Pitié-Salpétrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872598
- Sponsor's protocol ID
- AB09004
- Status last verified
- Sep 2023
- First submitted
- 5 Jun 2013
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dubois B, Lopez-Arrieta J, Lipschitz S, Doskas T, Spiru L, Moroz S, Venger O, Vermersch P, Moussy A, Mansfield CD, Hermine O, Tsolaki M; AB09004 Study Group Investigators. Masitinib for mild-to-moderate Alzheimer's disease: results from a randomized, placebo-controlled, phase 3, clinical trial. Alzheimers Res Ther. 2023 Feb 28;15(1):39. doi: 10.1186/s13195-023-01169-x.
PubMed 36849969
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Phase 3 Study to Evaluate the Safety and Efficacy of Masitinib in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01872598
- Acronym / sponsor ID
- AB09004
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, dementia, cognitive disease, memory loss, cerebrovascular disease, tyrosine kinase inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Jun 2013 (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 purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine.
Detailed description
Actual standard treatment for mild to moderately severe Alzheimer's dementia includes acetylcholinesterase inhibitors (donepezil, rivastigmine and galantamine) and a NMDA receptor antagonist (memantine for moderate to severe Alzheimer's disease). These medications have shown to have an effect on some cognitive and non cognitive symptoms of the pathology. However, their efficacy remains limited and may decrease with time. There is an unmet medical need in this pathology. Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes, as well as possibly disruption of the Aβ signaling cascade via inhibition of the Fyn signaling pathway. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of oral masitinib. The objective of this study is to compare the efficacy and safety of masitinib at various doses versus matched placebo in the treatment of patients with mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine. Approximately 675 patients will be randomized into 5 treatment groups. The co-primary outcome measures are the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL), and Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog) after 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Masitinib escalating dose | Experimental | Drug: Masitinib, Drug: Standard of careParticipants receive masitinib at 4.5 mg/kg/day, given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment |
| Masitinib fixed dose (4.5 mg/kg/day) | Experimental | Drug: Masitinib, Drug: Standard of careParticipants receive masitinib at 4.5 mg/kg/day, given orally twice daily. |
| Masitinib fixed dose (3.0 mg/kg/day) | Experimental | Drug: Masitinib, Drug: Standard of careParticipants receive masitinib at 3.0 mg/kg/day, given orally twice daily. |
| Placebo (escalating dose) | Placebo comparator | Drug: Placebo, Drug: Standard of careParticipants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment |
| Placebo (fixed dose) | Placebo comparator | Drug: Placebo, Drug: Standard of careParticipants receive fixed dose placebo, given orally twice daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with dementia of Alzheimer's type, according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
- Patient with probable Alzheimer' disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA)
- Patient with MMSE ≥ 12 and ≤ 25 at baseline
- Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline, and/or a stable dose of memantine for a minimum of 6 months at baseline, with no changes foreseen in therapy throughout the study.
Key exclusion criteria (2 listed)
- Patient with any other cause of dementia not due to Alzheimer's disease.
- Patient with Alzheimer disease with severe forms of delusions or delirium (patients with light and mild forms of delusions and delirium will be allowed in the study).
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 |
|---|---|---|
| MasitinibAlso: AB1010 | Drug | Masitinib escalating dose, Masitinib fixed dose (3.0 mg/kg/day), Masitinib fixed dose (4.5 mg/kg/day) |
| PlaceboAlso: Placebo Oral Tablet | Drug | Placebo (escalating dose), Placebo (fixed dose) |
| Standard of carestable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine, as per standard practice. | Drug | Masitinib escalating dose, Masitinib fixed dose (3.0 mg/kg/day), Masitinib fixed dose (4.5 mg/kg/day), Placebo (escalating dose), Placebo (fixed dose) |
Primary outcome
ADCS-ADL
Time frame: 24 weeks
Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL).
ADAS-Cog
Time frame: 24 weeks
Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog).
2 secondary outcomes
MMSE
Time frame: 24 weeks
CIBIC-plus
Time frame: 24 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 29 Sep 2023.
- Derived from this study: PubMed 36849969Dubois B, Lopez-Arrieta J, Lipschitz S, Doskas T, Spiru L, Moroz S, Venger O, Vermersch P, Moussy A, Mansfield CD, Hermine O, Tsolaki M; AB09004 Study Group Investigators. Masitinib for mild-to-moderate Alzheimer's disease: results from a randomized, placebo-controlled, phase 3, clinical trial. Alzheimers Res Ther. 2023 Feb 28;15(1):39. doi: 10.1186/s13195-023-01169-x.
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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.
Bruno DUBOIS, M.D., Ph.D. principal investigator
Pitié-Salpétrière
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib in people with Alzheimer Disease, run by AB Science 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 29 Sep 2023. 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 Bulgaria, Greece, Poland, Romania, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ADCS-ADL (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872598, which also lists 1 linked publication.
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 29 Sep 2023.