Trial · NCT02783573
A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia
NCT02783573, Phase 3, Terminated, AstraZeneca; results first posted 2019-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia. Trials, record NCT02783573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02783573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia
- NCT number
- NCT02783573
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,722 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Alzheimer's Disease
- Interventions
- Lanabecestat, Placebo
- First posted
- 2016-05-26
- Last updated
- 2019-12-03
- Other registries' IDs
- eudract:2015-005625-39
- 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 in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score | Baseline, Week 78 | 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, acetylcholinesterase Inhibitor (AChEI) use at baseline, pooled site, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction. |
| Secondary | Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL) | Baseline, Week 78 | 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, AChEI use at baseline, pooled site, and covariates for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction. |
| Secondary | Change From Baseline in Functional Activities Questionnaire (FAQ) Score | Baseline, Week 78 | 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 determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline FAQ total score, by-visit interaction and age at baseline. |
| Secondary | Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score | Baseline, Week 78 | 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 with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction. |
| Secondary | Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score | Baseline, Week 78 | The CDR-SB is a rater administered scale and impairment is scored in each of 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, AChEI use at baseline, pooled site, 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 | From Loss of 1 Global Stage through Week 78 | 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 78 | 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 a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, 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 78 | 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, AChEI use at baseline, pooled site, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction. |
| Secondary | Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42 | Baseline, Week 71 | 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 | Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40 | Baseline, Week 71 | 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 outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score | Baseline, Week 78 | 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 in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL) | Baseline, Week 78 | 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 in Functional Activities Questionnaire (FAQ) Score | Baseline, Week 78 | 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 78 | 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 in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score | Baseline, Week 78 | 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 | From Loss of 1 Global Stage through Week 78 | 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 78 | 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 78 | 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 | Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42 | Baseline, Week 71 | 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 | Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40 | Baseline, Week 71 | 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 outcomesResults by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score | Placebo | 6.42 | Standard Error 1.23 | Units on a scale | |
| Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score | Lanabecestat 20 mg | 8.93 | Standard Error 1.11 | Units on a scale | |
| Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score | Lanabecestat 50 mg | 6.20 | Standard Error 1.32 | Units on a scale | |
| Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL) | Placebo | -3.95 | Standard Error 1.27 | Units on a scale | |
| Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL) | Lanabecestat 20 mg | -6.91 | Standard Error 1.29 | Units on a scale | |
| Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL) | Lanabecestat 50 mg | -7.13 | Standard Error 1.40 | Units on a scale | |
| Change From Baseline in Functional Activities Questionnaire (FAQ) Score | Placebo | 3.93 | Standard Error 0.81 | Units on a scale | |
| Change From Baseline in Functional Activities Questionnaire (FAQ) Score | Lanabecestat 20 mg | 5.16 | Standard Error 0.85 | Units on a scale | |
| Change From Baseline in Functional Activities Questionnaire (FAQ) Score | Lanabecestat 50 mg | 3.41 | Standard Error 0.91 | Units on a scale | |
| Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score | Placebo | -10.46 | Standard Error 1.97 | Units on a scale |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-Controlled Treatment Period | STARTED | Placebo | 562 | |
| Placebo-Controlled Treatment Period | STARTED | Lanabecestat 20 Milligrams (mg) | 590 | |
| Placebo-Controlled Treatment Period | STARTED | Lanabecestat 50 mg | 570 | |
| Placebo-Controlled Treatment Period | Received at Least 1 Dose of Study Drug | Placebo | 558 | |
| Placebo-Controlled Treatment Period | Received at Least 1 Dose of Study Drug | Lanabecestat 20 Milligrams (mg) | 588 | |
| Placebo-Controlled Treatment Period | Received at Least 1 Dose of Study Drug | Lanabecestat 50 mg | 568 | |
| Placebo-Controlled Treatment Period | COMPLETED | Placebo | 26 | |
| Placebo-Controlled Treatment Period | COMPLETED | Lanabecestat 20 Milligrams (mg) | 28 | |
| Placebo-Controlled Treatment Period | COMPLETED | Lanabecestat 50 mg | 22 | |
| Placebo-Controlled Treatment Period | NOT COMPLETED | Placebo | 536 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events765
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 | Glaucoma | Eye disorders | Placebo-Period 1 | 5 | 558 | 5 |
| other | Glaucoma | Eye disorders | Lanabecestat 20 Mg-Period 1 | 4 | 588 | 4 |
| other | Glaucoma | Eye disorders | Lanabecestat 50 Mg-Period 1 | 3 | 568 | 3 |
| other | Glaucoma | Eye disorders | Lanabecestat 20 Mg-Period 2 | 1 | 14 | 1 |
| other | Glaucoma | Eye disorders | Lanabecestat 50 Mg-Period 2 | 0 | 12 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Period 1 | 17 | 558 | 19 |
| other | Diarrhoea | Gastrointestinal disorders | Lanabecestat 20 Mg-Period 1 | 29 | 588 | 35 |
| other | Diarrhoea | Gastrointestinal disorders | Lanabecestat 50 Mg-Period 1 | 29 | 568 | 39 |
| other | Diarrhoea | Gastrointestinal disorders | Lanabecestat 20 Mg-Period 2 | 0 | 14 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Lanabecestat 50 Mg-Period 2 | 0 | 12 | 0 |
1 to 10 of 765Source ClinicalTrials.gov
See all 765 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-Period 1 | 5 | 558 |
| Total, all-cause mortality | Lanabecestat 20 Mg-Period 1 | 2 | 588 |
| Total, all-cause mortality | Lanabecestat 50 Mg-Period 1 | 3 | 568 |
| Total, all-cause mortality | Lanabecestat 20 Mg-Period 2 | 0 | 14 |
| Total, all-cause mortality | Lanabecestat 50 Mg-Period 2 | 0 | 12 |
| Total, other adverse events | Placebo-Period 1 | 48 | 558 |
| Total, other adverse events | Lanabecestat 20 Mg-Period 1 | 69 | 588 |
| Total, other adverse events | Lanabecestat 50 Mg-Period 1 | 76 | 568 |
| Total, other adverse events | Lanabecestat 20 Mg-Period 2 | 5 | 14 |
| Total, other adverse events | Lanabecestat 50 Mg-Period 2 | 1 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02783573
GET https://conductscience.org/api/trials/v1/NCT02783573/results?page=2