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

Phase 1

Completed

• Conditions: Mild-Moderate Alzheimer's Disease; Healthy Elderly

• Registration Number: NCT02036645
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Study Start: 2014-02-04
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-15
• Results First Submitted: 2017-09-15
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Results First Posted: 2019-06-03
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability as Measured by Participant Withdrawal for an Adverse Event	4 months SAD; 7 months MAD	Tolerability measured by participant withdrawal for an adverse event from randomization through end of study

Secondary Outcome Measures

Name	Time	Method
Mean Termination Half Life (t 1/2) of Medi1814	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)
Maximum Plasma Concentration (Cmax) of Medi1814	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)
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	Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
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	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)
Biomarker: Total Amyloid-beta 1-42 in Plasma	Day 29 in SAD; Day 85 in MAD	Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Medi1814 Concentration in CSF Samples	SAD Day 29; MAD Day 85	Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Immunogenicity: Anti-drug Antibody Titer	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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Salt Lake City, Utah, United States