NCT02036645

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Typical duration for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

February 4, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

January 13, 2014

Results QC Date

September 15, 2017

Last Update Submit

February 21, 2019

Conditions

Mild-Moderate Alzheimer's DiseaseHealthy Elderly

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months SAD; 7 months MAD

Secondary Outcomes (7)

  • 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)

    1 month

  • Maximum Plasma Concentration (Cmax) of Medi1814

    1 month

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

    1 month

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

    Day 29 in SAD; Day 85 in MAD

  • Biomarker: Total Amyloid-beta 1-42 in Plasma

    Day 29 in SAD; Day 85 in MAD

  • +2 more secondary outcomes

Study Arms (4)

MEDI1814 IV

EXPERIMENTAL

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

IV Placebo

PLACEBO COMPARATOR

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 injectionBiological: IV Placebo

MEDI1814 Sub Cutaneous Injection

EXPERIMENTAL

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

Subcutaneous Placebo

PLACEBO COMPARATOR

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

Interventions

MEDI1814 for IV injectionBIOLOGICAL

Monoclonal antibody for IV Injection

IV PlaceboMEDI1814 IV
MEDI1814 for Subcutaneous InjectionBIOLOGICAL

Monoclonal antibody for subcutaneous injection

MEDI1814 Sub Cutaneous Injection
IV PlaceboBIOLOGICAL

Placebo for IV injection

IV Placebo
Placebo for Subcutaneous InjectionBIOLOGICAL

Subcutaneous Placebo Injection

Subcutaneous Placebo

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Long Beach, California, 90806, United States

Location

Research Site

Panorama City, California, 91402, United States

Location

Research Site

Hallandale, Florida, 33009, United States

Location

Research Site

Hialeah, Florida, 33012, United States

Location

Research Site

Miami, Florida, 33165, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Research Site

Baltimore, Maryland, 21225, United States

Location

Research Site

Oklahoma City, Oklahoma, 73112, United States

Location

Research Site

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

Injections, IntravenousInjections, Subcutaneous

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInjections

Limitations and Caveats

Although 11 subjects were in both a SAD and a MAD cohort, summaries were for those assigned to the cohort regardless of participation in any other cohort

Results Point of Contact

Title
Michael Pomfret, Project Director, IMED Neuroscience
Organization
AstraZeneca Pharmaceuticals
Clinicaltrialstransparency@astrazeneca.net

Study Officials

  • Thor Ostenfeld, MD

    AstraZeneca

    STUDY DIRECTOR

  • David Han, MD

    Glendale Parexel Early Phase Clinical Unit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

February 4, 2014

Primary Completion

September 15, 2016

Study Completion

September 15, 2016

Last Updated

June 3, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-02

Locations

US(10)