Identity XT

CompletedPhase 3Results posted

A Study of Semagacestat for Alzheimer's Patients

Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)

Lead sponsor

Eli Lilly and Company

Asset

Semagacestat

Listed sites

Recruiting sites

Enrollment

180

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•ADCS-Activities of Daily Living (ADCS-ADL)

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 ID5930

Secondary IDH6L-MC-LFBFEli Lilly and Company

NCT IDNCT01035138

Timeline

Milestones

Study start2009-12 (month precision)

Study first posted2009-12-18estimated

Primary completion2011-04actual (month precision)

Study completion2011-04actual (month precision)

Last update posted2014-09-25estimated

Results first posted2014-09-25estimated

Assets

Drug assets

Semagacestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease

•Completed semagacestat study LFAN or study LFBC through 88 weeks

•Must continue to have a reliable caregiver

•Capable of swallowing whole oral medication

•Agrees not to participate in other investigational compounds for the duration of study

Exclusion criteria

•Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study

Endpoints (34)

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

Memory

Global cognition

Function / daily living

Behavior / neuropsychiatric

Amyloid biomarkers

Neuroimaging

Caregiver / quality of life

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

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

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=63 Participants	4.18	0.53
LFAN LY 100 mg/ LY 140 mgn=52 Participants	2.99	0.58
LFAN LY 140 mg/LY 140 mgn=39 Participants	3.39	0.65

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=62 Participants	-4.67	0.78
LFAN LY 100 mg/ LY 140 mgn=51 Participants	-4.15	0.85
LFAN LY 140 mg/LY 140 mgn=41 Participants	-4.84	0.91

Memory

12 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
LFAN Placebo/LY140 mgn=41 Participants	6.4	11.53
LFAN LY 100 mg/ LY 140 mgn=40 Participants	12.5	12.82
LFAN LY 140 mg/LY 140 mgn=26 Participants	10.5	13.62

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=65 Participants	9.3	1.52
LFAN LY 100 mg/ LY 140 mgn=53 Participants	8.06	1.67
LFAN LY 140 mg/LY 140 mgn=43 Participants	11.56	1.79

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=65 Participants	10.35	1.60
LFAN LY 100 mg/ LY 140 mgn=53 Participants	9.09	1.75
LFAN LY 140 mg/LY 140 mgn=43 Participants	12.66	1.88

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=65 Participants	11.31	1.78
LFAN LY 100 mg/ LY 140 mgn=52 Participants	10.02	1.99
LFAN LY 140 mg/LY 140 mgn=43 Participants	14.50	2.10

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
LFAN Placebo/LY140 mgn=41 Participants	6.7	12.05
LFAN LY 100 mg/ LY 140 mgn=40 Participants	12.6	13.11
LFAN LY 140 mg/LY 140 mgn=26 Participants	11.2	14.97

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
LFAN Placebo/LY140 mgn=41 Participants	7.7	13.21
LFAN LY 100 mg/ LY 140 mgn=40 Participants	14.1	14.66
LFAN LY 140 mg/LY 140 mgn=26 Participants	13.3	16.93

Function / daily living

4 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug

Time frame:Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
LFAN Placebo/LY140 mgn=36 Participants	-4.5	7.73
LFAN LY 100 mg/ LY 140 mgn=33 Participants	-10.6	15.15
LFAN LY 140 mg/LY 140 mgn=21 Participants	-5.1	11.28

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=60 Participants	-12.34	2.11
LFAN LY 100 mg/ LY 140 mgn=50 Participants	-8.22	2.36
LFAN LY 140 mg/LY 140 mgn=36 Participants	-8.74	2.67

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in EuroQol-5D (EQ-5D) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=18 Participants	1.87	4.68
LFAN LY 100 mg/ LY 140 mgn=23 Participants	1.94	3.62
LFAN LY 140 mg/LY 140 mgn=9 Participants	3.62	6.43

Secondary/registry result

Change From Baseline in EuroQol-5D (EQ-5D) at Week 24

Time frame:Baseline (LFAN Randomization), 24 weeks (LFBF)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
LFAN Placebo/LY140 mgn=62 Participants	0.76	3.19
LFAN LY 100 mg/ LY 140 mgn=54 Participants	-2.23	3.38
LFAN LY 140 mg/LY 140 mgn=42 Participants	-14.44	3.67

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12

Time frame:Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

change from baseline, improvement

Secondary/registry result

Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12

Time frame:Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of change	Standard error
LFAN Placebo/LY140 mgn=11 Participants	-5.84	16.03
LFAN LY 100 mg/ LY 140 mgn=18 Participants	-6.09	9.01
LFAN LY 140 mg/LY 140 mgn=7 Participants	14.27	17.37

Secondary/registry result

Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

change from baseline, improvement

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cubic millimeter (mm³)	Standard error
LFAN Placebo/LY140 mgLeft hippocampal volumen=9 Participants	-115.39	83.61
Right hippocampal volumen=9 Participants	-141.79	81.00
LFAN LY 100 mg/ LY 140 mgLeft hippocampal volumen=7 Participants	-279.29	77.55
Right hippocampal volumen=7 Participants	-187.16	65.53
LFAN LY 140 mg/LY 140 mgLeft hippocampal volumen=3 Participants	22.49	107.49
Right hippocampal volumen=3 Participants	-3.86	99.85

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12

Time frame:Baseline (LFAN Randomization), 12 weeks (LFBF)

change from baseline, improvement

Posted result

Group	Value (mean), number of hospitalizations	Standard deviation
LFAN Placebo/LY140 mgn=5 Participants	1.80	1.92
LFAN LY 100 mg/ LY 140 mgn=3 Participants	0.67	0.58
LFAN LY 140 mg/LY 140 mgn=3 Participants	0.33	0.58

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Mean Concentration of LY450139

Time frame:3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)

concentration, descriptive

Secondary/registry result/low confidence

Mean Concentration of LY450139

Time frame:3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram/milliliter (ng/mL)	Geometric coefficient of variation
LY 140 mgPre-dose (n=7)n=46 Participants	1.81	124
2 hours after dosing (n=46)n=46 Participants	1160	66.9
4 hours after dosing (n=44)n=46 Participants	679	41.9
6 hours after dosing (n=41)n=46 Participants	341	52.6

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.