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

Phase 1CompletedNCT02036645

AstraZeneca77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Mild-Moderate Alzheimer's Disease Healthy Elderly

Interventions

MEDI1814 for IV injectionBIOLOGICAL

Monoclonal antibody for IV Injection

MEDI1814 for Subcutaneous InjectionBIOLOGICAL

Monoclonal antibody for subcutaneous injection

IV PlaceboBIOLOGICAL

Placebo for IV injection

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (10)

Research Site

Glendale, California, United States

Research Site

Long Beach, California, United States

Research Site

Panorama City, California, United States

Research Site

Hallandale, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 4 months SAD; 7 months MAD

Secondary Outcomes

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)

Time frame: 1 month

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)

Time frame: 1 month

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)

Time frame: 1 month

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

Time frame: Day 29 in SAD; Day 85 in MAD

Biomarker: Total Amyloid-beta 1-42 in Plasma

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

Time frame: Day 29 in SAD; Day 85 in MAD

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.