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Completed

NCT Number: NCT02036645

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

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.

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Key information

Conditions

Mild-moderate Alzheimer's Disease Healthy Elderly

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI1814 for IV injection

Biological

Monoclonal antibody for IV Injection

MEDI1814 for Subcutaneous Injection

Biological

Monoclonal antibody for subcutaneous injection

IV Placebo

Biological

Placebo for IV injection

Placebo for Subcutaneous Injection

Biological

Subcutaneous Placebo Injection

Primary outcomes

  1. Tolerability as Measured by Participant Withdrawal for an Adverse Event

    Time frame: 4 months SAD; 7 months MAD

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

Secondary outcomes

  1. 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)

    Time frame: 1 month

    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)

  2. Maximum Plasma Concentration (Cmax) of Medi1814

    Time frame: 1 month

    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)

  3. Mean Termination Half Life (t 1/2) of Medi1814

    Time frame: 1 month

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

  4. Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)

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

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

  5. Biomarker: Total Amyloid-beta 1-42 in Plasma

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

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

  6. Medi1814 Concentration in CSF Samples

    Time frame: SAD Day 29; MAD Day 85

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

  7. Immunogenicity: Anti-drug Antibody Titer

    Time frame: 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2014
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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