Health Trials

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)

ConditionAlzheimers Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-85
SponsorEisai Inc.

About this trial

The primary purpose of this study is to evaluate proof of mechanism (POM) and long-term safety and tolerability of E2511 in participants with Early AD. The study consists of 2 parts. In Part A, participants will be randomly assigned to receive either E2511 or donepezil. In Part B, participants will receive E2511 only. Once Part A and Part B participants complete the Core Trial (which includes Pretreatment and Treatment phases) they will have the option to enter the Extension Phase where they will receive E2511 for 18 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to AD-intermediate likelihood.

Have a global Clinical Dementia Rating Scale (CDR) score of 0.5 and a CDR Memory Box score of greater than or equal to (>=) 0.5 at Screening and Baseline.

Meet the NIA-AA core clinical criteria for probable AD dementia.

Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of >=0.5 at Screening and Baseline.

Disqualifiers

Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of trial drug.

total abstinence (if it is their preferred and usual lifestyle)

an intrauterine device or intrauterine hormone-releasing system (IUS)

a contraceptive implant

Trial design

Design model

Parallel

Treatments tested in this trial

  • E2511

    Drug

    E2511 oral tablets.

  • Donepezil

    Drug

    Donepezil oral tablets.

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Part A: E2511 Dose AExperimental treatment 1 intervention
Group B: Part A: Donepezil Dose AExperimental treatment 1 intervention
Group C: Part B: E2511 Dose BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A (Core Trial): Change from Baseline in [11C]MK-6884 Positron Emission Tomography (PET) Using Non-Displaceable Binding Potential (BPND) at 14 Days

Time frame
Baseline up to Day 14
2

Part A and B (Extension Phase): Number of Participants With Adverse Events (AEs)

Time frame
Up to 91 weeks
3

Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Vital Sign Values

Time frame
From Week 13 up to Week 91
4

Part A and B (Extension Phase): Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

Time frame
From Week 13 up to Week 91

Secondary outcomes

1

Part A and B (Core Trial): Number of Participants With AEs

Time frame
Part A: Up to 21 weeks; Part B: Up to 17 weeks
2

Part A and B (Core Trial): Number of Participants With Clinically Significant Changes in Vital Sign Values

Time frame
Part A: Up to 21 weeks; Part B: Up to 17 weeks
3

Part A and B (Core Trial): Number of Participants With Clinically Significant Changes in ECG Values

Time frame
Part A: Up to 21 weeks; Part B: Up to 17 weeks
4

Part A and B (Core Trial): Number of Participants With Clinically Significant Changes in Laboratory Safety Tests Values

Time frame
Part A: Up to 21 weeks; Part B: Up to 17 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisai Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: