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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036645
First Posted: January 15, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Mild-Moderate Alzheimer's Disease Healthy Elderly Biological: MEDI1814 for IV injection Biological: MEDI1814 for Subcutaneous Injection Biological: IV Placebo Biological: Placebo for Subcutaneous Injection Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To Assess Safety & Tolerability of MEDI1814 by a panel of adverse event measures: Physical exam, Vital signs, ECG, clinical laboratory testing, MRI, Columbia Suicide Severity Rating Scale [ Time Frame: All visits from screening up to 113 days post single dose/169 days post multiple dose ]
    Vital signs, ECG, clinical laboratory testing, MRI, Columbia Suicide Severity Rating Scale


Secondary Outcome Measures:
  • To Assess Pharmacokinetics of MEDI1814 in terms of: Cmax, Cmin, tmax, AUC, t1/2, CL and Vz for SAD and for MAD First dose: Cmax, Cmin, tmax, AUC and Third Dose: Cmax, Cmin, tmax, AUC, t1/2, CL, Vz, Vss and accumulation rations [ Time Frame: Baseline up to 113 days post single dose/169 days post multiple dose ]
    Blood samples will be taken for assessments. Single Ascending Dose: Cmax, Cmin, tmax, AUC, t1/2, CL and Vz. Mutiple Ascending Dose First dose: Cmax, Cmin, tmax, AUC, and for Third Dose: Cmax, Cmin, tmax, AUC, t1/2, CL, Vz, Vss and accumulation ratios

  • To Assess Pharmacodynamics of MEDI1814 in terms of a) blood biomarkers: total amyloid beta 1-42 and b) CSF biomarkers: total and free amyloid beta 1-42 and total amyloid beta 1-40 [ Time Frame: Baseline up to 113 days post single dose/169 days post multiple dose ]
    Blood and CSF samples will be taken for assessment. Blood biomarkers: total amyloid beta 1-42 and CSF biomarkers: total and free amyloid beta 1-42; total amyloid beta 1-40

  • To Assess Immunogenicity of MED1814 in terms of anti drug antibody detection [ Time Frame: Baseline up to 113 days post dose for single dose/169 days post multiple dose ]
    Blood samples will be taken for assessment of screening results and anti drug antibody (ADA) titre post dosing


Other Outcome Measures:
  • To Assess Exploratory Measures of ApoE genotype, central and peripheral protein biomarkers and MCI screen [ Time Frame: Basline up to 113 days post single dose/169 days post mutiple dose ]
    Samples will be taken to assess ApoE genotype, central and peripheral protein biomarkers. A novel cognitive assessment scale, the MCI screen, will be assessed for utility in future studies


Enrollment: 219
Study Start Date: February 2014
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI1814 IV
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Biological: MEDI1814 for IV injection
Monoclonal antibody for IV Injection
Placebo Comparator: IV Placebo
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Biological: MEDI1814 for IV injection
Monoclonal antibody for IV Injection
Biological: IV Placebo
Placebo for IV injection
Experimental: MEDI1814 Sub Cutaneous Injection
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Biological: MEDI1814 for Subcutaneous Injection
Monoclonal antibody for subcutaneous injection
Placebo Comparator: Subcutaneous Placebo
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Biological: Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036645


Locations
United States, California
Research Site
Glendale, California, United States
Research Site
Long Beach, California, United States
Research Site
Panorama City, California, United States
United States, Florida
Research Site
Hallandale Beach, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Thor Ostenfeld, MD AstraZeneca
Principal Investigator: David Han, MD Glendale Parexel Early Phase Clinical Unit
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02036645     History of Changes
Other Study ID Numbers: D4750C00001
First Submitted: January 13, 2014
First Posted: January 15, 2014
Last Update Posted: October 12, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders