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Alzheimer's DiseasePhase 2NCT00976118

Activity of Masitinib (AB1010) in Mild to Moderate Alzheimer's Disease

A Phase 2 study testing masitinib (AB1010) in people with Alzheimer's Disease, run by AB Science.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase 2 study was designed to evaluate the activity of oral masitinib (AB1010) administered at 2 dose levels during 24 weeks to patients with mild to moderate confirmed Alzheimer's type disease. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
masitinib (AB1010)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
No sites listed yet
Study dates
Feb 2006to Feb 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients from both sex
  • Age ≥ 50 years at screening
  • Menopause ≥ 2 years for women
  • Dementia of Alzheimer's type, according to DSM IV criteria
  • Probable Alzheimer' disease according to NINCDS-ADRDA criteria
  • MMSE ≥ 12 and ≤ 26 at baseline
Show all 11Show fewer
  • CDR of 1 or 2 at baseline
  • 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 3 months at baseline, with no changes foreseen in therapy throughout the study
  • Presence of a reliable caregiver
  • Patient, identified caregiver and, if applicable, patient surrogate are able and willing to comply with study visits and procedures per protocol, understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed
  • Affiliated to the French Social Security regimen

Who cannot join

  • Any cause of dementia not due to Alzheimer's disease :
  • other central nervous conditions causing progressive deficits in memory and cognition, e.g. cerebrovascular disease, Parkinson's disease, Huntington's disease, brain tumor…
  • systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection…
  • substance-induced conditions
  • Alzheimer disease with delusions or delirium
  • Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, galantamine, rivastigmine or memantine
Show all 15Show fewer
  • Uncontrolled depression at screening
  • Evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychotic disorder or hospitalization for psychiatric disorders
  • Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection.
  • History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening
  • Inadequate organ function, defined as follows : total bilirubin ≥ 1.5 x ULN, SGOT and SGPT ≥ 2.5 x UNL, creatinine clearance calculated by Crocroft method < 35 ml/mn, ANC ≤ 2500, platelets ≤ 100 000 at baseline
  • Treatment with any investigational agent within 4 weeks of screening,
  • Men and their partner refusing to use 2 methods of medically acceptable forms of contraception during the study.
  • History of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
  • Any condition that, in the investigator's opinion, could be detrimental to subjects participating in this study as life expectancy < 1 year, or any clinically important deviations from normal clinical laboratory values or concurrent medical events.

About this study

Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adults Patients With Mild to Moderate Alzheimer-type Disease.

This phase 2 study was designed to evaluate the activity of oral masitinib (AB1010) administered at 2 dose levels during 24 weeks to patients with mild to moderate confirmed Alzheimer's type disease.

Being tested
masitinib (AB1010), placebo
Keywords
Dementia of Alzheimer's type, mild to moderate Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • masitinib (AB1010)Drug

    Also called AB1010

    oral masitinib 3 or 6 mg/kg/day

  • placeboDrug

    matching placebo to masitinib

Study groups in NCT00976118
Study groupRoleWhat they receive
placeboPlacebo comparatorNot described
Receives: Drug: placebo
oral masitinib (AB1010)Experimentalmasitinib (AB1010) 3 or 6 mg/kg/day
Receives: Drug: masitinib (AB1010)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change from baseline in ADAS-Cog

    Measured: week 24

Secondary outcomes (3)

  1. change from baseline in CIBIC-plus

    Measured: week 24

  2. change from baseline in CDR

    Measured: week 24

  3. change from baseline in MMSE

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startFeb 2006
  3. Primary completionJul 2008
  4. Study completionFeb 2009

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976118
Sponsor's protocol ID
AB04024
Status last verified
Dec 2018
First submitted
11 Sep 2009
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet JP, Dubreuil P, Moussy A, Hermine O. Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial. Alzheimers Res Ther. 2011 Apr 19;3(2):16. doi: 10.1186/alzrt75.

    PubMed 21504563

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing masitinib (AB1010) in people with Alzheimer's Disease, run by AB Science.

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 11 inclusion and 15 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

change from baseline in ADAS-Cog (time frame: week 24). 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 NCT00976118, 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 13 Dec 2018.

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