Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.
Description: • PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF
Measure: Part A Non-compartmental PK parameters will be calculated and reported for ALZT-OP1a and ALZT-OP1b Time: • 2 DaysDescription: Evaluation AUC 0-∞ (area under the curve from 0 to infinity)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-∞ Time: 2 DaysDescription: Evaluation AUC 0-t (area under the curve from 0 to t hours where t is the last measured concentration)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-t Time: 2 DaysDescription: Evaluation AUCPLASMA/AUCCSF (ratio at 60 min, 120 min, 240 min, 360 min and 480 min)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUCPLASMA/AUCCSF Time: 2 DaysDescription: Evaluation CL/F (apparent total body clearance)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF CL/F Time: 2 DaysDescription: Evaluation Cmax (maximum plasma and CSF concentration observed)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Cmax Time: 2 DaysDescription: Evaluation t½ (half-life)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF t½ (half-life) Time: 2 DaysDescription: Evaluation tmax (sampling time at which Cmax occurred)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF tmax Time: 2 DaysDescription: Evaluation Vd/F (apparent volume of distribution)
Measure: PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Vd/F Time: 2 DaysDescription: Evaluation Beta Amyloid (Αβ-42)
Measure: Biomarker Beta Amyloid (Αβ-42) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Beta Amyloid (Αβ-40)
Measure: Biomarker Beta Amyloid (Αβ-40) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Beta Amyloid (Αβ-38)
Measure: Biomarker Beta Amyloid (Αβ-38) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Total Tau
Measure: Biomarker Total Tau Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Neurofilament light (Nf-L)
Measure: Biomarker Neurofilament light (Nf-L) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Glial Fibrillary Acidic Protein (GFAP)
Measure: Biomarker Glial Fibrillary Acidic Protein (GFAP) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation P-Tau (Thr 231)
Measure: Biomarker P-Tau (Thr 231) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Interferon-γ (IFN-γ)
Measure: Biomarker Interferon-γ (IFN-γ) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Tumor Necrosis Factor-α (TNF-α)
Measure: Biomarker Tumor Necrosis Factor-α (TNF-α) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Transforming Growth Factor-β1 (TGF-β1)
Measure: Biomarker Transforming Growth Factor-β1 (TGF-β1) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation CD33
Measure: Biomarker CD33 Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Triggering Receptor Expressed on Myeloid Cells-2 (TREM2)
Measure: Biomarker Triggering Receptor Expressed on Myeloid Cells-2 (TREM2) Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Evaluation Neurogranin
Measure: Biomarker Neurogranin Sample Analysis plasma and CSF Day 1 to 60 Days Time: Day 1 to Day 60Description: Safety will be evaluated based on the number, type, and frequency of treatment emergent adverse events. They will be individually presented for all subjects in data listings, and summarized in tables by treatment group and by treatment assignment. The AEs will be summarized and reported collectively based on information obtained through physical examination, ECG, and laboratory findings captured after dosing was initiated.
Measure: Number of Treatment Emergent Adverse Events (TEAE) Time: 2 Days Part A and 60Days Part BAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports