Phase 1
Completed N=45
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Mild-Moderate Alzheimer's Disease · Healthy Elderly
Source: ClinicalTrials.gov NCT02036645 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Tolerability as Measured by Participant Withdrawal for an Adverse Event — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability as Measured by Participant Withdrawal for an Adverse Event |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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) |
80.5; 455; 1550; 4040; 4420; 120 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Medi1814 |
10.2; 38.7; 102; 341; 424; 3.59 | — |
| SECONDARY Mean Termination Half Life (t 1/2) of Medi1814 |
17.2; 17.0; 17.1; 19.0; 18.3; 19.8 | — |
| SECONDARY Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed) |
122.9; -15.9; -21.0; 8.72; 2.0; 10.2 | — |
| SECONDARY Biomarker: Total Amyloid-beta 1-42 in Plasma |
19.6; 40132.5; 41107.0; 46667.9; 78534.5; 44050.9 | — |
| SECONDARY Medi1814 Concentration in CSF Samples |
0; 0; 1; 2; 4; 0 | — |
| SECONDARY Immunogenicity: Anti-drug Antibody Titer |
0; 0; 0; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02036645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.