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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

An Open-Label Phase 1b/2 Study to Assess Safety and Target Engagement of E2814 in Subjects With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

NCT04971733•Eisai Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, age 18 to 80 years at the time of informed consent
•2. 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
•3. Clinical Dementia Rating - Sum of Boxes (CDR-SB) score 5 to 12 at Screening
•4. Able to undergo magnetic resonance imaging (MRI), lumbar puncture (LP), PET, and complete all study-related testing and evaluations
•5. 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

•1. 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
•2. Females who are breastfeeding or pregnant at Screening or Baseline
•3. Females of childbearing potential who:
•Within 3 months before screening, did not use a highly effective method of contraception
•4. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease (AD)
•5. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening
•6. 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
•7. Any current psychiatric diagnosis or symptoms, (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
•8. Geriatric Depression Scale (GDS) score greater than or equal to 8 at Screening
•9. Contraindications to MRI scanning, including but not limited to pacemaker/cardiac defibrillator, neurostimulators, ferromagnetic metal implants (example, in skull and cardiac devices other than those approved as safe for use in MRI scanners)
+19 more criteria

Locations (3)

UC San Diego Altman Clinical and Translational Research Insititute Clinic

La Jolla, California, United States

Indiana University School of Medicine, Health Partners, Adult Neurology Clinic

Indianapolis, Indiana, United States

National Hospital for Neurology and Neurosurgery (NHNN) University College London(UCL) Hospitals NHS Foundation Trust

London, United Kingdom

Key Dates

Start Date

June 28, 2021

Primary Completion Date

May 24, 2024

Completion Date

May 24, 2024

Last Updated

June 10, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

E2814

DRUG

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

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RECRUITINGNA

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210

Alzheimer DiseaseLymphatic Obstruction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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