Alzheimer's DiseasePhase 2NAVIGATE-ADNCT02791191
A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
A Phase 2 study testing LY3202626 in people with Alzheimer's Disease, run by Eli Lilly and Company at 76 sites in 4 countries.
Trial summary
The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- LY3202626
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 76 sitesin 4 countries
- Study dates
- 16 Jun 2016to 2 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
- Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
- Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.
Who cannot join
- Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
- Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
- Use of strong inducers of cytochrome P450 3A (CYP3A).
- Sensitivity to florbetapir or ¹⁸F-AV-1451.
- Contraindication to MRI or PET or poor venous access for blood draws.
Trial locations and contacts
76 sites in 4 countries.
76 sites in 4 countries
United States49 sites
Abington Neurological Associates
Abington, Pennsylvania, 19090
Albany Medical College
Albany, New York, 12206
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Dent Neurological Institute
Amherst, New York, 14226
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
Missouri Memory Center
Bolivar, Missouri, 65613
Valley Medical Primary Care
Centerville, Ohio, 45459
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Clinical Research Professionals
Chesterfield, Missouri, 63005
Millenium Psychiatric Associates LLC
Creve Coeur, Missouri, 63141
Baylor AT&T Memory Center
Dallas, Texas, 75231
University of Cincinnati Health Neurology
Dayton, Ohio, 45417
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
United Osteoporosis Center
Gainesville, Georgia, 30501
Nantz National Alzheimer Center
Houston, Texas, 77030
University of Texas Health Services Center - Houston
Houston, Texas, 77054
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Irvine Clinical Research Center
Irvine, California, 92614
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256
Clinical Trial Center, LLC, Psychiatry
Jenkintown, Pennsylvania, 19046
St Lukes Hospital
Kansas City, Missouri, 64111
Las Vegas Medical Research
Las Vegas, Nevada, 89113
Compass Research
Melbourne, Florida, 32940
Florida International Research Center
Miami, Florida, 33173
New Horizon Research Center
Miami, Florida, 33175
The Neurology Research Group, LLC
Miami, Florida, 33176
Pyramid Clinical Research
Monroe, New Jersey, 08831
Suncoast Clinical Research
New Port Richey, Florida, 34652
Boston Center for Memory
Newton, Massachusetts, 02459
Renstar Medical Research
Ocala, Florida, 34470
Sensible Healthcare
Ocoee, Florida, 34761
Sutter Medical Group
Sacramento, California, 95816
Pacific Research Network Inc
San Diego, California, 92103
Sharp Mesa Vista Hospital
San Diego, California, 92123
Ray Dolby Brain Health Center/Sutter Health/CPMC
San Francisco, California, 94114
Syrentis Clinical Research
Santa Ana, California, 92705
North Bay Neuroscience Institute
Sebastopol, California, 95472
Insight Clinical Trials
Shaker Heights, Ohio, 44122
Meridien Research
Spring Hill, Florida, 34609
Washington University School of Medicine
St Louis, Missouri, 63108
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Axiom Research
Tampa, Florida, 33609
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755
Bio Behavioral Health
Toms River, New Jersey, 08755
Cotton O'Neil Clinic
Topeka, Kansas, 66606
Heartland Research Associates
Wichita, Kansas, 67205
Christiana Care Health Service
Wilmington, Delaware, 19801
Japan14 sites
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Akashi, 673-0891
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Hachiōji, 193-0998
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Ikeda, 563-0058
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Kasukabe-shi, 344-0036
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Kyoto, 606-0851
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Nagoya, 451-8511
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Nerima-ku, 179-0072
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Osaka, 533-0004
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Osaka, 559-0004
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Setagaya-ku, 158-8531
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Takamatsu, 760-8557
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Tokyo, 156-0041
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Wako, 351-0111
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Yokosuka-shi, 238-0042
Australia10 sites
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Box Hill, 3128
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Chermside, 4032
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Darlinghurst, 2010
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Erina, 2250
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Glen Iris, 3146
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Heidelberg, 3084
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Herston, 4029
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Nedlands, 6009
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Parkville, 3050
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West Perth, 6005
Canada3 sites
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Gatineau, J8T 8J1
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Ottawa, KIN 5C8
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Verdun, H4H 1R3
About this study
Official title: Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia
The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.
- Conditions
- Alzheimer's Disease
- Being tested
- LY3202626, Placebo
- Keywords
- BACE inhibitor
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3202626Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 LY3202626 | Experimental | 3 mg LY3202626 given orally once daily for 52 weeks. Receives: Drug: LY3202626 |
| Dose 2 LY3202626 | Experimental | 12 mg LY3202626 given orally once daily for 52 weeks. Receives: Drug: LY3202626 |
| Placebo | Experimental | Placebo given orally once daily for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.
Measured: Baseline, Week 52
Secondary outcomes (8)
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Percentage of participants with treatment-emergent MRI findings at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
Measured: Week 52
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Percentage of participants with presence of amyloid-related imaging abnormalities-edema (ARIA-E, also known as vasogenic edema) and percentage of an increase in amyloid-related imaging abnormalities-hemorrhage (ARIA-H, also known as also known as microhemorrhage) at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
Measured: Week 52
Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which includes a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present during the period up through randomization. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Measured: Baseline through Week 52
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
PK: AUC [T,SS] of LY3202626
Measured: Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
A mixed model repeated measures (MMRM) analysis will be used to evaluate the change from baseline to Week 52 in plasma Aβ₁-₄₀, Aβ₁-₄₂, and Aβ 1-x. The model for the fixed effects will include terms for the following independent effects: log transformed baseline plasma Aβ, treatment, visit, treatment-by-visit interaction.
Measured: Baseline, Week 52
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. A mixed model repeated measures (MMRM) was used in analysis. The model included fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Measured: Baseline, Week 52
Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
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 (instrumental activity items 7-23) of daily living by participants. The range for the ADCS-iADL is 0-56 with higher scores reflecting better performance. ADCS-iADL was analyzed using mixed-model repeated measures (MMRM), Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
Measured: Baseline, Week 52
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
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 9score range 0 to 85 with higher scores reflecting worse performance and the ADCS-iADL (score range 0-56 with higher scores reflecting better performance). The iADRS score ranges from 0 to 141 with lower scores indicating worse performance. iADRS was analyzed using mixed-model repeated measures (MMRM); Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start16 Jun 2016
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Why it stopped: Low likelihood of identifying a statistically significant treatment effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791191
- Sponsor's protocol ID
- 16223
- Other IDs
- I7X-MC-LLCF
- Acronym
- NAVIGATE-AD
- Status last verified
- Mar 2021
- First submitted
- 1 Jun 2016
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia
- ClinicalTrials.gov ID
- NCT02791191
- Acronym / sponsor ID
- NAVIGATE-AD / 16223
- Conditions
- Alzheimer's Disease
- Keywords
- BACE inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low likelihood of identifying a statistically significant treatment effect.
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 LY3202626 | Experimental | Drug: LY32026263 mg LY3202626 given orally once daily for 52 weeks. |
| Dose 2 LY3202626 | Experimental | Drug: LY320262612 mg LY3202626 given orally once daily for 52 weeks. |
| Placebo | Experimental | Drug: PlaceboPlacebo given orally once daily for 52 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
- Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
- Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.
Key exclusion criteria (5 listed)
- Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
- Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
- Use of strong inducers of cytochrome P450 3A (CYP3A).
- Sensitivity to florbetapir or ¹⁸F-AV-1451.
- Contraindication to MRI or PET or poor venous access for blood draws.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3202626Administered orally | Drug | Dose 1 LY3202626, Dose 2 LY3202626 |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Time frame: Baseline, Week 52
The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.
8 secondary outcomes
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Time frame: Week 52
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Time frame: Week 52
Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Time frame: Baseline through Week 52
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
Time frame: Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
Time frame: Baseline, Week 52
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
Time frame: Baseline, Week 52
Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Time frame: Baseline, Week 52
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
76 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3202626 in people with Alzheimer's Disease, run by Eli Lilly and Company at 76 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Japan, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.