NCT04971733 is a Phase 1, PHASE2 clinical trial of E2814 in Alzheimer Disease, sponsored by Eisai Inc..

Who is sponsoring NCT04971733?

NCT04971733 is sponsored by Eisai Inc..

What drugs are being tested in NCT04971733?

Interventions in NCT04971733: E2814.

What condition does NCT04971733 study?

NCT04971733 studies Alzheimer Disease.

Is NCT04971733 still recruiting?

NCT04971733 is currently completed. Last updated 10 June 2025.

Are results published for NCT04971733?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-10 · How we verify

NCT04971733

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 10 June 2025

What this trial tests

Phase 1, PHASE2 trial testing E2814 in Alzheimer Disease in 8 participants. Completed in 24 May 2024.

Timeline

28 June 2021

Primary endpoint
24 May 2024

24 May 2024

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	28 June 2021
Primary completion	24 May 2024
Estimated completion	24 May 2024
Sites	3 locations across United Kingdom, United States

Drugs / interventions tested

E2814 — full drug profile →

Conditions studied

Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Primary · From first dose of study drug up to 120 weeks

A TEAE was defined as adverse event (AE) that started at or after the time of administration of study drug or a worsening of severity from Baseline on or after 1st dose up to last assessment. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product. SAE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this d

TEAEs

Group	Value	95% CI
Cohort A: E2814 750 mg	4
Cohort A: E2814 1500 mg	1
Cohort A+B: E2814 3000 mg	8
Cohort A: E2814 4500 mg	4

Serious TEAEs

Group	Value	95% CI
Cohort A: E2814 750 mg	0
Cohort A: E2814 1500 mg	0
Cohort A+B: E2814 3000 mg	2
Cohort A: E2814 4500 mg	1

Number of Participants With Markedly Abnormal Laboratory Values Primary · From first dose of study drug up to 120 weeks

Clinical laboratory tests included hematology, clinical chemistry, and urinalysis assessments. Markedly abnormal value was defined as a post-baseline value with an increase from baseline to a grade of 2 or higher on Common Terminology Criteria for Adverse events (CTCAE) Version 5.0 scale.

Group	Value	95% CI
Cohort A: E2814 750 mg	0
Cohort A: E2814 1500 mg	1
Cohort A+B: E2814 3000 mg	1
Cohort A: E2814 4500 mg	2

Number of Participants With Clinically Significant Change in Vital Signs Values Primary · From first dose of study drug up to 120 weeks

Vital sign measurements included systolic and diastolic blood pressure, pulse, respiratory rate, body temperature, height and weight assessment. The clinically significant assessment was based on investigator judgement.

Group	Value	95% CI
Cohort A: E2814 750 mg	0
Cohort A: E2814 1500 mg	0
Cohort A+B: E2814 3000 mg	0
Cohort A: E2814 4500 mg	0

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings Primary · From first dose of study drug up to 120 weeks

The clinically significant assessment was based on investigator judgement.

Group	Value	95% CI
Cohort A: E2814 750 mg	0
Cohort A: E2814 1500 mg	0
Cohort A+B: E2814 3000 mg	0
Cohort A: E2814 4500 mg	0

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 Primary · Pre-dose at Week 12

Total MTBR-Tau was the total of bound MTBR-Tau + free MTBR-Tau. CSF samples were collected for the assessment.

Change in CSF Free MTBR-tau354

Group	Value	95% CI
Cohort A: E2814 750 mg	-0.0534	± 0.0690

Change in CSF Free MTBR-tau299

Group	Value	95% CI
Cohort A: E2814 750 mg	-0.0147	± 0.0267

Change in CSF Bound MTBR-tau354

Group	Value	95% CI
Cohort A: E2814 750 mg	0.178	± 0.0886

Change in CSF Bound MTBR-tau299

Group	Value	95% CI
Cohort A: E2814 750 mg	0.0420	± 0.0194

Change in CSF Total MTBR-tau354

Group	Value	95% CI
Cohort A: E2814 750 mg	0.125	± 0.0899

Change in CSF Total MTBR-tau299

Group	Value	95% CI
Cohort A: E2814 750 mg	0.0273	± 0.0191

Cohort A, Cmax: Maximum Observed Plasma Concentration for E2814 Secondary · Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

The concentration of E2814 were measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.

Group	Value	95% CI
Cohort A: E2814 750 mg	218	± 25.9
Cohort A: E2814 1500 mg	499	± 24.3

Cohort A, Tmax: Time to Reach the Maximum Plasma Concentration for E2814 Secondary · Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

The concentration of E2814 was measured by validated electrochemiluminescence assay methods and/or by a validated immunoprecipitation/purification followed by liquid chromatography with tandem mass spectrometry methods.

Group	Value	95% CI
Cohort A: E2814 750 mg	1.00	1.00 – 5.00
Cohort A: E2814 1500 mg	1.00	1.00 – 5.00

Cohort A, AUC(0-672h): Area Under the Plasma Concentration-time Curve From Zero Time to 672 Hours for E2814 Secondary · Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	66500	± 23.2

Cohort A, Cmax: Maximum Observed Serum Concentration for E2814 Secondary · Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	41.7	± 64.1
Cohort A: E2814 1500 mg	101	± 47.1

Cohort A, Tmax: Time to Reach the Maximum Serum Concentration for E2814 Secondary · Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	1.00	1.00 – 25.00
Cohort A: E2814 1500 mg	5.00	1.00 – 9.00

Cohort A, AUC(0-672h): Area Under the Serum Concentration-time Curve From Zero Time to 672 Hours for E2814 Secondary · Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	8030	± 54.8

Cohort A: CSF Concentrations of E2814 Secondary · Pre-dose at Days 1, 84, 85, 169, 253, 421, and 757

Day 1: Pre-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	0	± 0

Day 84: Pre-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	172	± 77.8

Day 85: Pre-dose

Group	Value	95% CI
Cohort A: E2814 750 mg	153	± 32.2

Day 169: Pre-dose

Group	Value	95% CI
Cohort A: E2814 1500 mg	429	± 212

Day 253: Pre-dose

Group	Value	95% CI
Cohort A: E2814 3000 mg	806	± 426

Day 421: Pre-dose

Group	Value	95% CI
Cohort A: E2814 3000 mg	1035	± 35.4

Day 757: Pre-dose

Group	Value	95% CI
Cohort A: E2814 4500 mg	1611	± 1567

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to 120 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A: E2814 750 mg

Serious: 0/7 (0%)

Deaths: 0/7

Cohort A: E2814 1500 mg

Serious: 0/7 (0%)

Deaths: 0/7

Cohort A+B: E2814 3000 mg

Serious: 2/8 (25%)

Deaths: 0/8

Cohort A: E2814 4500 mg

Serious: 1/4 (25%)

Deaths: 0/4

Serious adverse events (5 terms)

Reaction	System	Cohort A: E2814 750 mg	Cohort A: E2814 1500 mg	Cohort A+B: E2814 3000 mg	Cohort A: E2814 4500 mg
Lower respiratory tract infection	Infections and infestations	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Cerebral venous sinus thrombosis	Nervous system disorders	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—
Vaginal haemorrhage	Reproductive system and breast disorders	—	—	—	—

Other adverse events (44 terms — click to expand)

Reaction	System	Cohort A: E2814 750 mg	Cohort A: E2814 1500 mg	Cohort A+B: E2814 3000 mg	Cohort A: E2814 4500 mg
COVID-19	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Bundle branch block left	Cardiac disorders	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Gait disturbance	General disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—
Fungal infection	Infections and infestations	—	—	—	—
Fungal skin infection	Infections and infestations	—	—	—	—
Genital herpes	Infections and infestations	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Clavicle fracture	Injury, poisoning and procedural complications	—	—	—	—
Eye injury	Injury, poisoning and procedural complications	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Chronic lymphocytic leukaemia recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Aphasia	Nervous system disorders	—	—	—	—
Bradykinesia	Nervous system disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Hemiapraxia	Nervous system disorders	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—
Myoclonus	Nervous system disorders	—	—	—	—
Tension headache	Nervous system disorders	—	—	—	—
Agitation	Psychiatric disorders	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—
Delusion	Psychiatric disorders	—	—	—	—
Hallucination	Psychiatric disorders	—	—	—	—
Hallucination, visual	Psychiatric disorders	—	—	—	—
Hypertonic bladder	Renal and urinary disorders	—	—	—	—
Micturition urgency	Renal and urinary disorders	—	—	—	—

Most-reported serious reactions: Lower respiratory tract infection, Arthritis, Cerebral venous sinus thrombosis, Seizure, Vaginal haemorrhage.

Data from ClinicalTrials.gov NCT04971733 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in Alzheimer's disease: Mechanisms, clinical trials and new drug development strategies.
Zhang J, Zhang Y, Wang J, Xia Y, et al · · 2024 · cited 489× · PMID 39174535 · DOI 10.1038/s41392-024-01911-3
Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
Alzheimer's disease drug development pipeline: 2023.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
Tau and neuroinflammation in Alzheimer's disease: interplay mechanisms and clinical translation.
Chen Y, Yu Y. · · 2023 · cited 275× · PMID 37452321 · DOI 10.1186/s12974-023-02853-3
Tau-targeting therapies for Alzheimer disease: current status and future directions.
Congdon EE, Ji C, Tetlow AM, Jiang Y, et al · · 2023 · cited 246× · PMID 37875627 · DOI 10.1038/s41582-023-00883-2
Tauopathies: new perspectives and challenges.
Zhang Y, Wu KM, Yang L, Dong Q, et al · · 2022 · cited 212× · PMID 35392986 · DOI 10.1186/s13024-022-00533-z
Alzheimer's disease drug development pipeline: 2024.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465
Immunotherapy for Alzheimer's disease: targeting β-amyloid and beyond.
Song C, Shi J, Zhang P, Zhang Y, et al · · 2022 · cited 160× · PMID 35300725 · DOI 10.1186/s40035-022-00292-3

Verify or expand the search:

Other trials of E2814

Trials testing the same drug.

NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting
NCT04231513 — A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous · Phase 1 · completed

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Currently open trials in the same condition.

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NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting

Other Eisai Inc. trials

Trials by the same sponsor.

NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04971733 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 10 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04971733.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing