MissionAD1

TerminatedPhase 3Results posted

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

Lead sponsor

Eisai Co., Ltd.

Asset

Elenbecestat

Listed sites

258

Recruiting sites

Enrollment

2,212

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD / mild AD dementia•Amyloid biomarker required (PET/CSF)•CDR global 0.5•MMSE ≥24•MRI contraindications excluded

Primary endpoints

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•Treatment-emergent Adverse Events (TEAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2016-003928-23

Eudract number2016-004128-42

Org study IDE2609-G000-301

NCT IDNCT02956486

Timeline

Milestones

Study start2016-10-20actual

Study first posted2016-11-07estimated

Primary completion2020-01-15actual

Study completion2020-01-15actual

Last update posted2021-02-03actual

Results first posted2021-02-03actual

Assets

Drug assets

Elenbecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Core Study

•Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including

1. Mini Mental State Examination score equal to or greater than 24

2. Clinical Dementia Rating (CDR) global score of 0.5

3. CDR Memory Box score of 0.5 or greater

•Impaired episodic memory confirmed by a list learning task

•Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography or cerebrospinal fluid AD assessment or both

Extension Phase

• Participants who complete the Core Study

Exclusion criteria

Core Study

•Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation

•Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD

•Participants with a history of seizures within 5 years of Screening

•History of transient ischemic attacks or stroke within 12 months of Screening

•Psychiatric diagnosis or symptoms (example, hallucinations, major depression, delusions etc.)

•Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years

•Have any contraindications to magnetic resonance imaging (MRI) scanning or

1. Have lesions that could indicate a dementia diagnosis other than AD on brain MRI

2. Exhibit other significant pathological findings on brain MRI.

•Participants who have a history of moderate to severe hepatic impairment (example, Child-Pugh Class B or C)

•Results of laboratory tests conducted during Screening that are outside the following limits:

1. Absolute lymphocyte count below the lower limit of normal (LLN)

2. Thyroid stimulating hormone above normal range

3. Abnormally low Vitamin B12 levels

•Participants at increased risk of infection

•Have received any live vaccine/live attenuated vaccine in the 3 months before randomization

•Any chronic inflammatory disease that is not adequately controlled or that requires systemic immunosuppressive or immunomodulatory therapy

•Any other clinically significant abnormalities

•Severe visual or hearing impairment

•A prolonged corrected QT (QTc) interval (QT interval with Fridericia's correction [QTcF] greater than 450 milliseconds [ms])

•Malignant neoplasms within 5 years of Screening

•Known or suspected history of drug or alcohol abuse

•Taking prohibited medications, which must be reviewed with the Investigator

•Have participated in a recent clinical study

Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Executive function / language

Disease progression

Behavior / neuropsychiatric

Amyloid biomarkers

Global cognition

24 endpoints

Primary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1078 Participants	2.17	0.142
Core Phase: Elenbecestat 50 mgn=1053 Participants	1.99	0.146

Least Square (LS) Mean Difference-0.1795% CI-0.57 - 0.22p0.385MMRM

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24

Time frame:Up to Month 24 of the core phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the MMSE Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Last Dose in the CDR-SB Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow up (up to Month 27)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Secondary/protocol endpoint

Core Phase: Change From Last Dose in the ADCOMS

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

descriptive

Secondary/protocol endpoint

Core Phase: Change From Last Dose in the MMSE Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/protocol endpoint

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in CDR-SB Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Secondary/protocol endpoint

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADCOMS

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

ADAS-Cog

descriptive

Secondary/protocol endpoint

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in MMSE Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1018 Participants	0.24	0.014
Core Phase: Elenbecestat 50 mgn=981 Participants	0.23	0.015

LS Mean Difference-0.0295% CI-0.06 - 0.02p0.345MMRM

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=664 Participants	1.97	0.157
Core Phase: Elenbecestat 50 mgn=617 Participants	1.74	0.169

LS Mean Difference-0.2395% CI-0.67 - 0.22p0.316MMRM

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=627 Participants	0.23	0.017
Core Phase: Elenbecestat 50 mgn=571 Participants	0.20	0.018

LS Mean Difference-0.0395% CI-0.07 - 0.02p0.254MMRM

Secondary/registry result

Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24

Time frame:Up to Month 24 of the core phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), change in score per year	Reported bounds
Core Phase: Placebon=1084 Participants	0.934	-0.838 - 1.030
Core Phase: Elenbecestat 50 mgn=1062 Participants	0.926	-0.828 - 1.024

Difference of Mean Slope-0.00895% CI-0.145 - 0.129p0.9088Linear mixed effects model

Based on the linear mixed effects model, which included assessment time and treatment group by assessment time interaction as covariate with random intercept and slope.

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the MMSE Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1056 Participants	-2.87	0.234
Core Phase: Elenbecestat 50 mgn=1017 Participants	-2.87	0.241

LS Mean Difference-0.0195% CI-0.64 - 0.62p0.977MMRM

Secondary/registry result

Core Phase: Change From Last Dose in the CDR-SB Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow up (up to Month 27)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=759 Participants	0.40	0.045
Core Phase: Elenbecestat 50 mgn=734 Participants	0.44	0.046

LS Mean Difference0.0495% CI-0.09 - 0.17p0.542MMRM

Secondary/registry result

Core Phase: Change From Last Dose in the ADCOMS

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=666 Participants	0.06	0.005
Core Phase: Elenbecestat 50 mgn=646 Participants	0.06	0.005

LS Mean Difference-0.0195% CI-0.02 - 0.01p0.380MMRM

Secondary/registry result

Core Phase: Change From Last Dose in the MMSE Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Mini-Mental State Examination (MMSE)

ratio, descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=734 Participants	-0.22	0.101
Core Phase: Elenbecestat 50 mgn=719 Participants	-0.26	0.102

LS Mean Difference-0.0495% CI-0.32 - 0.24p0.799MMRM

Secondary/registry result

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in CDR-SB Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Secondary/registry result

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADCOMS

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

ADAS-Cog

descriptive

Secondary/registry result

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in MMSE Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Mini-Mental State Examination (MMSE)

ratio, descriptive

Memory

18 endpoints

Secondary/protocol endpoint

Core Phase: Time to Worsening of CDR Score up to Month 24

Time frame:Up to Month 24 of the core phase

time to event, event

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition11 (ADAS-Cog11) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Core Phase: Change From Last Dose in the ADAS-cog11 Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

descriptive

Secondary/protocol endpoint

Core Phase: Change From Last Dose in the ADAS-cog14 Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

descriptive

Secondary/protocol endpoint

Core Phase: Change From Last Dose in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

event count, event

Secondary/protocol endpoint

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

ADAS-Cog

descriptive

Secondary/protocol endpoint

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

ADAS-Cog

event count, event

Secondary/registry result

Core Phase: Time to Worsening of CDR Score up to Month 24

Time frame:Up to Month 24 of the core phase

time to event, event

Posted result

Group	Value (median), months	Reported bounds
Core Phase: Placebon=1084 Participants	NA	-NA - NA
Core Phase: Elenbecestat 50 mgn=1062 Participants	NA	-24.07 - NA

Hazard Ratio (HR)0.9595% CI0.77 - 1.16p0.6155Regression, Cox

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1010 Participants	5.38	0.490
Core Phase: Elenbecestat 50 mgn=972 Participants	4.95	0.520

LS Mean Difference-0.4395% CI-1.75 - 0.90p0.525MMRM

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1050 Participants	1.63	0.195
Core Phase: Elenbecestat 50 mgn=1005 Participants	1.36	0.207

LS Mean Difference-0.2795% CI-0.79 - 0.26p0.314MMRM

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition11 (ADAS-Cog11) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1010 Participants	4.11	0.370
Core Phase: Elenbecestat 50 mgn=972 Participants	4.18	0.391

LS Mean Difference0.0795% CI-0.93 - 1.07p0.895MMRM

Secondary/registry result

Core Phase: Change From Last Dose in the ADAS-cog11 Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=679 Participants	0.95	0.150
Core Phase: Elenbecestat 50 mgn=647 Participants	0.56	0.153

LS Mean Difference-0.4095% CI-0.82 - 0.02p0.063MMRM

Secondary/registry result

Core Phase: Change From Last Dose in the ADAS-cog14 Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=679 Participants	0.96	0.196
Core Phase: Elenbecestat 50 mgn=647 Participants	0.40	0.201

LS Mean Difference-0.5695% CI-1.11 - -0.01p0.045MMRM

Secondary/registry result

Core Phase: Change From Last Dose in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Time frame:From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

ADAS-Cog

event count, event

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=707 Participants	0.54	0.088
Core Phase: Elenbecestat 50 mgn=685 Participants	0.22	0.090

LS Mean Difference-0.3295% CI-0.56 - -0.07p0.012MMRM

Secondary/registry result

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

ADAS-Cog

descriptive

Secondary/registry result

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

ADAS-Cog

event count, event

Executive function / language

4 endpoints

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

change from baseline, improvement

Secondary/protocol endpoint

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in FAQ Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

event count, event

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=1038 Participants	5.20	0.448
Core Phase: Elenbecestat 50 mgn=1001 Participants	5.32	0.459

LS Mean Difference0.1195% CI-1.09 - 1.32p0.854MMRM

Secondary/registry result

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in FAQ Score

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

event count, event

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase

event count, event

Primary/registry result

Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Extension Phase: Elenbecestat 50 mgn=18 Participants	6	-

Disease progression

4 endpoints

Secondary/protocol endpoint

Core Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 24

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

time to event, event

Secondary/protocol endpoint

Extension Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 12 of the Extension Phase

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

time to event, event

Secondary/registry result

Core Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 24

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

time to event, event

Posted result

Group	Value (median), months	Reported bounds
Core Phase: Placebon=902 Participants	23.05	-21.14 - 24.66
Core Phase: Elenbecestat 50 mgn=901 Participants	21.40	-20.45 - 24.43

Hazard Ratio (HR)1.1495% CI0.96 - 1.35p0.1281Regression, Cox

Based on a Cox regression model which included treatment group, concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.

Secondary/registry result

Extension Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 12 of the Extension Phase

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

time to event, event

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)

Time frame:Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Core Phase: Placebon=268 Participants	7.81	2.500
Core Phase: Elenbecestat 50 mgn=248 Participants	-5.02	2.046

LS Mean Difference-12.8395% CI-18.79 - -6.88p<.001MMRM

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.