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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02036645
Other study ID # D4750C00001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 4, 2014
Est. completion date September 15, 2016

Study information

Verified date February 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date September 15, 2016
Est. primary completion date September 15, 2016
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease

Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MEDI1814 for IV injection
Monoclonal antibody for IV Injection
MEDI1814 for Subcutaneous Injection
Monoclonal antibody for subcutaneous injection
IV Placebo
Placebo for IV injection
Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection

Locations

Country Name City State
United States Research Site Baltimore Maryland
United States Research Site Glendale California
United States Research Site Hallandale Beach Florida
United States Research Site Hialeah Florida
United States Research Site Long Beach California
United States Research Site Miami Florida
United States Research Site Oklahoma City Oklahoma
United States Research Site Orlando Florida
United States Research Site Panorama City California
United States Research Site Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability as Measured by Participant Withdrawal for an Adverse Event Tolerability measured by participant withdrawal for an adverse event from randomization through end of study 4 months SAD; 7 months MAD
Secondary 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) 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) 1 month
Secondary Maximum Plasma Concentration (Cmax) of Medi1814 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) 1 month
Secondary Mean Termination Half Life (t 1/2) 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) 1 month
Secondary Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed) Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline Day 29 in SAD; Day 85 in MAD
Secondary Biomarker: Total Amyloid-beta 1-42 in Plasma Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline Day 29 in SAD; Day 85 in MAD
Secondary Medi1814 Concentration in CSF Samples Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification SAD Day 29; MAD Day 85
Secondary Immunogenicity: Anti-drug Antibody Titer Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)
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