Trial · NCT04381468
SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer's Disease (AD)
NCT04381468, Phase 1, Phase 2, Completed, Vaccinex Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer's Disease (AD). Trials, record NCT04381468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04381468
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer's Disease (AD)
- NCT number
- NCT04381468
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Vaccinex Inc.
- Conditions
- Alzheimer Disease
- Interventions
- Pepinemab, Placebo
- First posted
- 2020-05-08
- Last updated
- 2024-08-22
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of subjects with treatment emergent adverse events (TEAEs) | Up to 40 weeks | TEAEs are defined as Adverse events (AEs) with onset after date-time of first dose, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. |
| Secondary | Effects on brain metabolism | Up to 36 weeks | As assessed by \[18F\]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 20 mg/kg or 40 mg/kg pepinemab or placebo. |
| Secondary | Alzheimer's Disease Assessment Scale- Cognitive subscale (ADAS-cog13) | Up to 36 weeks | The Alzheimer's Disease Assessment Scale (ADAS-cog13) will be performed to test the cognition of subjects. The score ranges from 0 to 75，and higher values represent a better outcome. |
| Secondary | Clinical Dementia Rating (CDR) | Up to 36 weeks | The CDR assesses 3 domains of cognition (memory, orientation, judgment/problem solving) and 3 domains of function (community affairs, home/hobbies, personal care) using semi-structured interviews of both the study subject and an informant carried out by a trained rater. The CDR is scored using a standard methodology. Each domain is rated on a 5-point scale and lower numbers represent a better outcome. |
| Secondary | Mini Mental State Examination (MMSE) | Up to 36 weeks | Mini-Mental State Examination scores(MMSE) will be performed to test the cognition of subjects. The score ranges from 0 to 30，and higher values represent a better outcome. |
| Secondary | Alzheimer's Disease Cooperative Study - Activities of Daily Living | Up to 36 weeks | The ADCS-ADL assesses the competence of participants with AD in basic and instrumental activities of daily living (ADLs). It is administered by a clinician as a structured interview with a caregiver. The maximum score is 30. A higher score is better. |
| Secondary | Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) | Up to 36 weeks | The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome. |
| Secondary | Neuropsychiatric Inventory (NPI) | Up to 36 weeks | The NPI is a trial partner interview-based rating scale assessing 12 behavioral disturbances occurring in dementia subjects. Items are scored for both frequency and severity. Total scores range from 0-144 with higher scores indicating greater behavioral disturbances. For each item, the associated trial partner distress is also assessed. |
| Secondary | Immunogenicity of pepinemab in serum | Up to 36 weeks | As assessed by the frequency and titer of anti-drug antibodies. |
| Other | Peak serum concentration (Cmax) | Up to 36 weeks | PK parameter |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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.
Papers31
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/NCT04381468
GET https://conductscience.org/api/trials/v1/NCT04381468/registered?page=2