Trial · NCT05564169
Masitinib in Patients With Mild Alzheimer's Disease
NCT05564169, Phase 3, Not yet recruiting, AB Science
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Masitinib in Patients With Mild Alzheimer's Disease. Trials, record NCT05564169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05564169
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Masitinib in Patients With Mild Alzheimer's Disease
- NCT number
- NCT05564169
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 600 participants, estimated
- Lead sponsor
- AB Science
- Conditions
- Alzheimer Disease
- Interventions
- Placebo, Masitinib (4.5), Standard of care
- First posted
- 2022-10-03
- Last updated
- 2025-10-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute change from baseline in iADRS score at week 24 | 24 weeks | The iADRS is a linear combination of its two components: the ADAS-Cog11 and the ADCS-iADL. The iADRS is calculated as follows: iADRS = ADCS-iADL + (70 - ADAS-Cog11). Lower scores on the iADRS indicate greater impairment; iADRS scores range from 0 to 129. |
| Secondary | Absolute change from baseline in Mini-Mental State Examination (MMSE) at week 24 | 24 weeks | Mini-Mental State Examination (MMSE) (scores from 0 to 30, with lower scores indicating poorer cognitive performance) |
| Secondary | Absolute change from baseline in ADAS-Cog11 score at week 24 | 24 weeks | The global score, which is the sum of the 11 items, ranges from 0 to 70, with higher scores indicating greater cognitive impairment. |
| Secondary | Absolute change from baseline in ADCS-ADL score | 48 weeks | Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL) (scores from 0 to 78, with lower scores indicating worse function) |
| Secondary | Clinical Responder rate | 24 weeks | Clinical response defined as decrease from baseline at week 24 in ADAS-cog of ≥4, without deterioration in ADCS-ADL (ADCS-ADL change ≥ 0 between baseline and timepoint) or worsening in the CIBIC-plus scale (response CIBIC in 1-3\] or no change \[CIBIC in 4\]). |
| Secondary | CIBIC-plus | 24 weeks | Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), a seven-point categorical rating scale ranging from 1 (marked improved) to 7 (markedly worse) compared with baseline. |
| Secondary | Absolute change from baseline in CDR | 24 weeks | Clinical Dementia Rating (CDR), scores from 0 to 18, with higher scores indicating worse dementia |
| Secondary | Time to severe dementia (MMSE<10) | 24 weeks | Mini-Mental State Examination (MMSE) (scores from 0 to 30, with lower scores indicating poorer cognitive performance) |
| Secondary | Absolute change from baseline in ADAS-Cog11 score at week 48 | 48 weeks | The global score, which is the sum of the 11 items, ranges from 0 to 70, with higher scores indicating greater cognitive impairment. |
| Secondary | Absolute change from baseline in ADCS-ADL score at week 24 | 24 weeks | Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL) (scores from 0 to 78, with lower scores indicating worse function) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05564169
GET https://conductscience.org/api/trials/v1/NCT05564169/registered