Clinical trial NCT02036645: SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild-Moderate Alzheimer's Disease
Healthy Elderly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 77
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Tolerability as Measured by Participant Withdrawal for an Adverse Event
timeFrame: 4 months SAD; 7 months MAD
Secondary outcomes:
measure: 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)
timeFrame: 1 month
measure: Maximum Plasma Concentration (Cmax) of Medi1814
timeFrame: 1 month
measure: Mean Termination Half Life (t 1/2) of Medi1814
timeFrame: 1 month
measure: Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
timeFrame: Day 29 in SAD; Day 85 in MAD
measure: Biomarker: Total Amyloid-beta 1-42 in Plasma
timeFrame: Day 29 in SAD; Day 85 in MAD
measure: Medi1814 Concentration in CSF Samples
timeFrame: SAD Day 29; MAD Day 85
measure: Immunogenicity: Anti-drug Antibody Titer
timeFrame: 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Panorama City
country: United States
facility: Research Site
state: California
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: AstraZeneca
name: Thor Ostenfeld, MD
role: STUDY_DIRECTOR
affiliation: Glendale Parexel Early Phase Clinical Unit
name: David Han, MD
role: PRINCIPAL_INVESTIGATOR
References: