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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02036645
First received: January 13, 2014
Last updated: April 4, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 242
Study Start Date: February 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036645

Contacts
Contact: Robert C Alexander, MD ClinicalTrialTransparency@astrazeneca.com

Locations
United States, California
Research Site Recruiting
Glendale, California, United States
United States, Florida
Research Site Not yet recruiting
Hallandale Beach, Florida, United States
Research Site Not yet recruiting
Orlando, Florida, United States
United States, Kentucky
Research Site Not yet recruiting
Lexington, Kentucky, United States
United States, Maryland
Research Site Not yet recruiting
Baltimore, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Robert C Alexander, MD AstraZeneca
Principal Investigator: David Han, MD Glendale Parexel Early Phase Clinical Unit
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02036645     History of Changes
Other Study ID Numbers: D4750C00001
Study First Received: January 13, 2014
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014