Trial · NCT02245737

An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease

NCT02245737, Phase 2, Phase 3, Terminated, AstraZeneca; results first posted 2019-08-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease. Trials, record NCT02245737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02245737

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease
NCT number: NCT02245737
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 2,218 participants, actual
Lead sponsor: AstraZeneca
Conditions: Alzheimer´s Disease
Interventions: Lanabecestat, Placebo
First posted: 2014-09-22
Last updated: 2019-12-03
Other registries' IDs: eudract:2014-002601-38
Results first posted: 2019-08-06
Limitations and caveats: An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	Baseline, Week 104	ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.
Secondary	Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)	Baseline, Week 104	The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.
Secondary	Change From Baseline on the Functional Activities Questionnaire (FAQ) Score	Baseline, Week 104	FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did \[the activity\] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.
Secondary	Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score	Baseline, Week 104	The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.
Secondary	Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Baseline, Week 104	The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.
Secondary	Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage	Baseline through Loss of 1 Global Stage or Week 104	The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).
Secondary	Change From Baseline in Neuropsychiatric Inventory (NPI) Score	Baseline, Week 104	The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.
Secondary	Change From Baseline on the Mini-Mental State Examination (MMSE)	Baseline, Week 104	The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.
Secondary	Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42	Baseline, Week 97	Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.
Secondary	PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40	Baseline, Week 97	Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on the Functional Activities Questionnaire (FAQ) Score	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR-SB.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage	Baseline through Loss of 1 Global Stage or Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR Global Score.	Days	MEDIAN
SECONDARY	Change From Baseline in Neuropsychiatric Inventory (NPI) Score	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for NPI.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on the Mini-Mental State Examination (MMSE)	Baseline, Week 104	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42	Baseline, Week 97	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-42.	Percent change in Aβ1-42	LEAST_SQUARES_MEAN
SECONDARY	PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40	Baseline, Week 97	All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-40.	Percent change in Aβ1-40	LEAST_SQUARES_MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	Placebo	10.31	Standard Error 0.55	Units on a scale
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	Lanabecestat 20 mg	9.38	Standard Error 0.56	Units on a scale
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	Lanabecestat 50 mg	10.72	Standard Error 0.58	Units on a scale
Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)	Placebo	-8.87	Standard Error 0.60	Units on a scale
Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)	Lanabecestat 20 mg	-8.84	Standard Error 0.61	Units on a scale
Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)	Lanabecestat 50 mg	-8.79	Standard Error 0.63	Units on a scale
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score	Placebo	6.09	Standard Error 0.38	Units on a scale
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score	Lanabecestat 20 mg	5.96	Standard Error 0.39	Units on a scale
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score	Lanabecestat 50 mg	6.71	Standard Error 0.40	Units on a scale
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score	Placebo	-19.56	Standard Error 0.99	Units on a scale

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	740
Overall Study	STARTED	Lanabecestat 20 Milligrams (mg)	739
Overall Study	STARTED	Lanabecestat 50 mg	739
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	738
Overall Study	Received at Least 1 Dose of Study Drug	Lanabecestat 20 Milligrams (mg)	736
Overall Study	Received at Least 1 Dose of Study Drug	Lanabecestat 50 mg	735
Overall Study	COMPLETED	Placebo	187
Overall Study	COMPLETED	Lanabecestat 20 Milligrams (mg)	184
Overall Study	COMPLETED	Lanabecestat 50 mg	168
Overall Study	NOT COMPLETED	Placebo	553

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events882

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Placebo	39	738	44
other	Diarrhoea	Gastrointestinal disorders	Lanabecestat 20 mg	62	736	81
other	Diarrhoea	Gastrointestinal disorders	Lanabecestat 50 mg	54	735	62
other	Nausea	Gastrointestinal disorders	Placebo	32	738	38
other	Nausea	Gastrointestinal disorders	Lanabecestat 20 mg	33	736	39
other	Nausea	Gastrointestinal disorders	Lanabecestat 50 mg	41	735	50
other	Nasopharyngitis	Infections and infestations	Placebo	60	738	69
other	Nasopharyngitis	Infections and infestations	Lanabecestat 20 mg	78	736	94
other	Nasopharyngitis	Infections and infestations	Lanabecestat 50 mg	76	735	89
other	Upper respiratory tract infection	Infections and infestations	Placebo	46	738	57

1 to 10 of 882Source ClinicalTrials.gov

See all 882 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	738
Total, all-cause mortality	Lanabecestat 20 mg	4	736
Total, all-cause mortality	Lanabecestat 50 mg	4	735
Total, other adverse events	Placebo	340	738
Total, other adverse events	Lanabecestat 20 mg	357	736
Total, other adverse events	Lanabecestat 50 mg	361	735
Total, serious adverse events	Placebo	108	738
Total, serious adverse events	Lanabecestat 20 mg	117	736
Total, serious adverse events	Lanabecestat 50 mg	147	735

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27767991	DERIVED	PubMed
31764959	DERIVED	PubMed
33049114	DERIVED	PubMed
40603145	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Delayed Recall Module	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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