NAVIGATE-AD

TerminatedPhase 2Results posted

A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia

Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia

Lead sponsor

Eli Lilly and Company

Asset

LY3202626

Listed sites

Recruiting sites

Enrollment

316

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild AD dementia•Amyloid biomarker required (PET)•MMSE 20-26•MRI contraindications excluded

Primary endpoint

•¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio

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

Org study ID16223

Secondary IDI7X-MC-LLCFEli Lilly and Company

NCT IDNCT02791191

Timeline

Milestones

Study first posted2016-06-06estimated

Study start2016-06-16actual

Primary completion2018-07-02actual

Study completion2018-07-02actual

Last update posted2021-04-19actual

Results first posted2021-04-19actual

Assets

Drug assets

LY3202626

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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.

Endpoints (18)

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

Amyloid biomarkers

Function / daily living

Behavior / neuropsychiatric

Tau biomarkers

Neuroimaging

Safety / tolerability / PK

Global cognition

4 endpoints

Secondary/protocol endpoint

Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)

Time frame:Baseline, Week 52

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 52

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)

Time frame:Baseline, Week 52

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
3 mg LY3202626n=17 Participants	3.05	1.40
12 mg LY3202626n=19 Participants	1.88	1.33
Placebon=15 Participants	2.97	1.51

p0.970Mixed Model Repeated Measures

p0.586Mixed Model Repeated Meausres

Secondary/registry result

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:Baseline, Week 52

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
3 mg LY3202626n=16 Participants	-6.01	2.07
12 mg LY3202626n=19 Participants	-6.45	1.90
Placebon=15 Participants	-10.32	2.15

p0.153ANCOVA

p0.176ANCOVA

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)

Time frame:Baseline, Week 52

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)

Time frame:Baseline, Week 52

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
3 mg LY3202626n=17 Participants	-3.97	1.34
12 mg LY3202626n=19 Participants	-4.63	1.24
Placebon=15 Participants	-7.32	1.38

p0.088ANCOVA

p0.150ANCOVA

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/registry result

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

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
3 mg LY3202626TE Suicidal Ideationn=55 Participants	7.27	-
TE Suicidal Behaviorn=55 Participants	1.82	-
12 mg LY3202626TE Suicidal Ideationn=127 Participants	7.09	-
TE Suicidal Behaviorn=126 Participants	0.79	-
PlaceboTE Suicidal Ideationn=133 Participants	3.76	-
TE Suicidal Behaviorn=133 Participants	0.00	-

p0.452Fisher Exact

Treatment Emergent Suicidal Ideation

p0.279Fisher Exact

p0.293Fisher Exact

Emergence of Suicidal Behavior

p0.486Fisher Exact

Emergence of Suicidal Behavior

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)

Time frame:Week 52

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
3 mg LY3202626Presence of Vasogenic Edeman=41 Participants	0.0	-
Increase in Microhemorrhagesn=41 Participants	4.7	-
12 mg LY3202626Presence of Vasogenic Edeman=75 Participants	0.0	-
Increase in Microhemorrhagesn=75 Participants	6.3	-
PlaceboPresence of Vasogenic Edeman=62 Participants	1.6	-
Increase in Microhemorrhagesn=62 Participants	7.5	-

p1.000Fisher Exact

Vasogenic Edema

p0.457Fisher Exact

Vasogenic Edema

p0.703Fisher Exact

Increase in Microhemorrhage

p1.000Fisher Exact

Increase in Microhemorrhage

Secondary/registry result

Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), nanograms per liter (ng/L)	Standard deviation
3 mg LY3202626Amyloid Betan=13 Participants	-258.7	64
Amyloid Beta 1-40n=14 Participants	-157.3	65.6
Amyloid Beta 1-42n=14 Participants	-46.3	38.7
12 mg LY3202626Amyloid Betan=17 Participants	-286.1	85.9
Amyloid Beta 1-40n=17 Participants	-149.3	38.0
Amyloid Beta 1-42n=17 Participants	-50.0	34.1
PlaceboAmyloid Betan=14 Participants	-12.0	80.5
Amyloid Beta 1-40n=15 Participants	-17.0	38.2
Amyloid Beta 1-42n=15 Participants	0.0	5.8

p<.001ANCOVA

Amyloid Beta

p<.001ANCOVA

Amyloid Beta 1-40

p<.001ANCOVA

Amyloid Beta 1-40

p<.001ANCOVA

Amyloid Beta 1-42

p<.001ANCOVA

Amyloid Beta 1-42

Tau biomarkers

2 endpoints

Primary/protocol endpoint

Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks

Time frame:Baseline, Week 52

change from baseline, improvement

Primary/registry result

Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Standard Uptake Value Ratio (SUVr)	Standard deviation
3 mg LY3202626n=15 Participants	0.02	0.04
12 mg LY3202626n=15 Participants	0.03	0.04
Placebon=11 Participants	0.01	0.08

p0.418ANCOVA

p0.231ANCOVA

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings

Time frame:Week 52

threshold achievement, improvement

Secondary/registry result

Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings

Time frame:Week 52

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
3 mg LY3202626White Matter Diseasen=41 Participants	2.4	-
Cortical Infarctn=41 Participants	2.4	-
Cortical Superficial Siderousn=41 Participants	0.0	-
Lacunar Infarctn=41 Participants	0.0	-
Other Infarctn=41 Participants	0.0	-
12 mg LY3202626White Matter Diseasen=75 Participants	1.3	-
Cortical Infarctn=75 Participants	0.0	-
Cortical Superficial Siderousn=75 Participants	1.3	-
Lacunar Infarctn=75 Participants	0.0	-
Other Infarctn=75 Participants	0.0	-
PlaceboWhite Matter Diseasen=62 Participants	1.6	-
Cortical Infarctn=62 Participants	0.0	-
Cortical Superficial Siderousn=62 Participants	0.0	-
Lacunar Infarctn=62 Participants	1.6	-
Other Infarctn=62 Participants	1.6	-

p1.000Fisher Exact

White Matter Disease

p1.000Fisher Exact

White Matter Disease

p0.404Fisher Exact

p1.000Fisher Exact

Cortical Superficial Siderous

p1.000Fisher Exact

p0.457Fisher Exact

Lacunar Infarct

p1.000Fisher Exact

Other Infarct

p0.457Fisher Exact

Other Infarct

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/registry result

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

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	Geometric coefficient of variation
3 mg LY3202626n=55 Participants	158	55.1
12 mg LY3202626n=127 Participants	641	58.0

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.