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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.

2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort

The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.

SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects with Mild-Moderate Alzheimer’s Disease.

NCT ID

Therapeutic Area

Monoclonal antibody for subcutaneous injection

Research Site

A Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814 in Subjects with Mild to Moderate Alzheimer’s Disease.

Vital signs, ECG, clinical laboratory testing, MRI, Columbia Suicide Severity Rating Scale

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Mini Mental State Exam (MMSE) - indicator of dementia; range of score of enrolled subjects 16 to 26, Scale range 0 to 30, higher score worse

Mini Mental State Exam (MMSE)

Study Specific Characteristic

All randomized subjects, Safety Analysis Population

Although 11 subjects were in both a SAD and a MAD cohort, summaries were for those assigned to the cohort regardless of participation in any other cohort

Tolerability measured by participant withdrawal for an adverse event from randomization through end of study

Tolerability as measured by participant withdrawal for an adverse event

First Dose (day 1-29)

Third dose (day 57-85)

Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)

Pharmacokinetic Population (subjects treated with Medi1814)

Area Under the Concentration time curve (AUC) time 0 to t (28 days after 1st dose SAD and MAD and after 3rd dose in MAD, day 57)

First dose (day 1-29)

Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)

Pharmacokinetic population (subjects dosed with Medi1814)

Maximum plasma concentration (Cmax) of Medi1814

Mean termination half life (t 1/2)  of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)

Mean termination half life (t 1/2) of Medi1814

Total amyloid-beta 1-40

Total amyloid-beta 1-42

Free amyloid-beta 1-42

Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline

Pharmacodynamic population (with non zero baseline values)

Biomarkers: Amyloid-beta in cerebral spinal fluid (two Amyloid bets peptides of 40 and 42 amino acids were assessed)

Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline

Biomarker: Total Amyloid-beta 1-42 in plasma

Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification

Medi1814 concentration in CSF samples

Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50

Immunogenicity: Anti-drug antibody titer

SAD Cohorts : Study Part 1

MAD cohorts: Study Part 2

Due to population (mild to moderate Alzheimer's disease) and duration (6 or 9 months) per cohort, rescreening was permitted. SAD had 128 screeings in105 subjects (23 rescreens); MAD had 133 screenings in 88 subjects, (22 rescreens from SAD and 23 rescreens from MAD).  Note: 11 of 32 randomized MAD subjects had previously completed a SAD cohort.

Michael Pomfret, Project Director, IMED Neuroscience

﻿Blood samples will be taken for assessments. Single Ascending Dose: Cmax, Cmin, tmax, AUC, t1/2, CL and Vz. Mutiple Ascending Dose First dose: Cmax, Cmin, tmax, AUC, and for Third Dose: Cmax, Cmin, tmax, AUC, t1/2, CL, Vz, Vss and accumulation ratios

Blood and CSF samples will be taken for assessment. Blood biomarkers: total amyloid beta 1-42 and CSF biomarkers: total and free amyloid beta 1-42; total amyloid beta 1-40

Blood samples will be taken for assessment of screening results and anti drug antibody (ADA) titre post dosing

Arms	Assigned Interventions
Experimental: MEDI1814 IV Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.	Biological/Vaccine: MEDI1814 for IV injection Monoclonal antibody for IV Injection
Placebo Comparator: IV Placebo Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.	Biological/Vaccine: MEDI1814 for IV injection Monoclonal antibody for IV Injection Biological/Vaccine: IV Placebo Placebo for IV injection
Experimental: MEDI1814 Sub Cutaneous Injection 2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort	Biological/Vaccine: MEDI1814 for Subcutaneous Injection Monoclonal antibody for subcutaneous injection
Placebo Comparator: Subcutaneous Placebo 2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort	Biological/Vaccine: Placebo for Subcutaneous Injection Subcutaneous Placebo Injection

SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects with Mild-Moderate Alzheimer’s Disease.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator