Trial · NCT04381468
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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 |
| Other | Area under the serum concentration vs. time curve (AUC) | Up to 36 weeks | PK parameter |
| Other | Half-life of pepinemab | Up to 36 weeks | PK parameter |
| Other | Serum and CSF levels of neuroinflammatory cytokines | Up to 36 weeks | IL-1, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL13,IFNγ, TNF-α, TGFβ |
| Other | T- and B-Cell Quantitation by Flow Cytometry (TBNK) | Up to 36 weeks | B cells, total count; Natural killer (NK) cells, total count; T cells, total count; Absolute CD4/CD8 count with ratio |
| Other | Plasma and CSF concentration of neurofilament light chain (NfL) | Up to 36 weeks | |
| Other | Plasma and CSF concentrations of Aβ1-42/Aβ1-40 | Up to 36 weeks | |
| Other | CSF levels of pepinemab | Up to 36 weeks | |
| Other | CSF concentrations of tau and p-tau | Up to 36 weeks | |
| Other | CSF concentrations of YKL-40 | Up to 36 weeks | |
| Other | Cellular SEMA4D levels | Up to 36 weeks | PD parameter to determine the level of SEMA4D expression on T lymphocytes |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04381468/registered