A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cog… (NCT04971733) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease
United States, United Kingdom8 participantsStarted 2021-06-28
Plain-language summary
The primary objective of the study is to assess the safety and tolerability of intravenous (IV) infusions of E2814 in participants with dominantly inherited Alzheimer's disease (DIAD), and to evaluate target engagement (TE) of E2814 on microtubule binding region (MTBR)-tau species in cerebrospinal fluid (CSF) in participants with DIAD.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female, age 18 to 80 years at the time of informed consent
✓. Individuals who are confirmed to be mutation positive for presenilin 1 (PSEN1), amyloid precursor protein (APP), or presenilin 2 (PSEN2) gene that is associated with DIAD
✓. Clinical Dementia Rating - Sum of Boxes (CDR-SB) score 5 to 12 at Screening
✓. Able to undergo magnetic resonance imaging (MRI), lumbar puncture (LP), PET, and complete all study-related testing and evaluations
✓. Has a study partner who in the investigator's judgment is able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion
Exclusion criteria
✕. Clinically significant illness that required medical treatment within 8 weeks before the 1st dose or a clinically significant infection that required medical treatment within 4 weeks before 1st dose
✕. Females who are breastfeeding or pregnant at Screening or Baseline
✕. Females of childbearing potential who:
✕. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease (AD)
✕. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening
✕
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Timeframe: From first dose of study drug up to 120 weeks
2
Number of Participants With Markedly Abnormal Laboratory Values
Timeframe: From first dose of study drug up to 120 weeks
3
Number of Participants With Clinically Significant Change in Vital Signs Values
Timeframe: From first dose of study drug up to 120 weeks
4
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Timeframe: From first dose of study drug up to 120 weeks
5
Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks
. History of clinically important carotid or vertebrobasilar stenosis, plaque, or other prominent risk factor for stroke or cerebral haemorrhage (including atrial fibrillation and anticoagulation). Low dose aspirin (less than or equal to \[\<=\] 325 milligram \[mg\] daily) is not exclusionary
✕. Any current psychiatric diagnosis or symptoms, (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
✕. Geriatric Depression Scale (GDS) score greater than or equal to 8 at Screening