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

NCT02036645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-06-03

Study results available
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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.

Conditions

  • Mild-Moderate Alzheimer's Disease
  • Healthy Elderly

Interventions

BIOLOGICAL

MEDI1814 for IV injection

Monoclonal antibody for IV Injection

BIOLOGICAL

MEDI1814 for Subcutaneous Injection

Monoclonal antibody for subcutaneous injection

BIOLOGICAL

IV Placebo

Placebo for IV injection

BIOLOGICAL

Placebo for Subcutaneous Injection

Subcutaneous Placebo Injection

Sponsors & Collaborators

Principal Investigators

  • Thor Ostenfeld, MD · AstraZeneca

  • David Han, MD · Glendale Parexel Early Phase Clinical Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-04
Primary Completion
2016-09-15
Completion
2016-09-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02036645 on ClinicalTrials.gov