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

Healthy Elderly Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036645
• Other study ID #: D4750C00001
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Elderly
• Mild-Moderate Alzheimer's Disease

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)