TerminatedPhase 1 / PHASE2Results posted

Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

LY2886721

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD•Amyloid biomarker required•MMSE 20-30

Primary endpoints

•Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations•CSF Aβ1-40 and Aβ1-42 Concentrations

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 ID13735

Eudract number2011-005217-37

Secondary IDI4O-MC-BACCEli Lilly and Company

NCT IDNCT01561430

Timeline

Milestones

Study start2012-03 (month precision)

Study first posted2012-03-23estimated

Primary completion2013-08actual (month precision)

Study completion2013-08actual (month precision)

Last update posted2018-05-18actual

Results first posted2018-05-18actual

Assets

Drug assets

LY2886721

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Meets criteria for MCI due to AD or Mild AD

All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening

•Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the criteria for mild AD, as follows:

-Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD

-Clinical Dementia Rating Scale (CDR) score of 0.5 or 1

-Positive scan for the presence of amyloid beta

•Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following criteria:

-Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months

-Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46

-Absence of dementia

-Preservation of functional independence

-Exclusion of other potential (vascular, traumatic, or medical) causes of cognitive decline, where possible

-Positive scan for the presence of amyloid beta

•Women must be postmenopausal

•Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods

Exclusion criteria

•Participant in another drug or device study

•Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy (PSNP), or other movement disorder

•Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than 2 months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed.

•Have had a serious infectious disease affecting the brain in the past 5 years

•Have had a serious or repeat head injury

•Have significant retinal impairment or disease

•Have had a stroke or other circulation problems that are affecting current health

•Have had a seizure

•Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) criteria for major depression may be included

•History of schizophrenia, bipolar disorder, or severe mental illness

•History of alcohol or drug abuse

•Have asthma, chronic obstructive pulmonary disease (COPD), or other breathing disease that is not controlled with medicine

•Have human immunodeficiency virus (HIV) or syphilis

•Are taking blood thinners

Endpoints (16)

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

Tau biomarkers

Global cognition

8 endpoints

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

Time frame:Baseline, 26 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Time frame:Baseline, 26 weeks

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)

Time frame:Baseline, 26 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)

Time frame:Baseline, 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
15 mg LY2886721n=8 Participants	-0.039	0.1096
35 mg LY2886721n=7 Participants	-0.161	0.1165
70 mg LY2886721n=1 Participants	0.424	0.3156
Placebon=9 Participants	-0.262	0.1028

Secondary/registry result

Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

Time frame:Baseline, 26 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
15 mg LY2886721n=7 Participants	1.1	2.77
35 mg LY2886721n=9 Participants	0.6	2.48
70 mg LY2886721n=1 Participants	0.6	7.41
Placebon=9 Participants	1.3	2.44

Secondary/registry result

Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Time frame:Baseline, 26 weeks

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
15 mg LY2886721n=8 Participants	0.80	0.432
35 mg LY2886721n=9 Participants	0.52	0.395
70 mg LY2886721n=1 Participants	1.50	1.013
Placebon=8 Participants	1.19	0.402

Secondary/registry result

Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)

Time frame:Baseline, 26 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
15 mg LY2886721n=8 Participants	-0.7	0.87
35 mg LY2886721n=9 Participants	-1.8	0.81
70 mg LY2886721n=1 Participants	0.2	2.41
Placebon=10 Participants	-3.0	0.77

Amyloid biomarkers

6 endpoints

Primary/protocol endpoint

Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations

Time frame:Baseline, 12 weeks

percent change from baseline, improvement

Primary/protocol endpoint

Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations

Time frame:Baseline, 26 weeks

percent change from baseline, improvement

Primary/registry result

Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations

Time frame:Baseline, 12 weeks

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change in Aβ1-40 and Aβ1-42	Standard error
15 mg LY2886721Aβ1-40n=7 Participants	-31.8	7.35
Aβ1-42n=7 Participants	-34.4	7.27
35 mg LY2886721Aβ1-40n=9 Participants	-57.7	6.67
Aβ1-42n=9 Participants	-52.0	6.80
70 mg LY2886721Aβ1-40n=5 Participants	-58.9	8.73
Aβ1-42n=5 Participants	-60.7	8.42
PlaceboAβ1-40n=11 Participants	3.7	5.96
Aβ1-42n=12 Participants	6.5	6.06

Primary/registry result

Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations

Time frame:Baseline, 26 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations

Time frame:Baseline, 12 weeks, 26 weeks

percent change from baseline, improvement

Secondary/registry result

Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations

Time frame:Baseline, 12 weeks, 26 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change in Aβ1-40 and Aβ1-42	Standard deviation
15 mg LY2886721Aβ1-40, Week 12n=6 Participants	-73.4	6.22
Aβ1-40, Week 26n=5 Participants	-72.3	11.5
Aβ1-42, Week 12n=6 Participants	-63.4	6.11
Aβ1-42, Week 26n=5 Participants	-65.1	8.85
35 mg LY2886721Aβ1-40, Week 12n=8 Participants	-80.8	8.07
Aβ1-40, Week 26n=6 Participants	-85.0	3.89
Aβ1-42, Week 12n=8 Participants	-71.1	8.38
Aβ1-42, Week 26n=6 Participants	-75.0	4.33
70 mg LY2886721Aβ1-40, Week 12n=4 Participants	-88.1	2.66
Aβ1-40, Week 26n=1 Participants	-89.1	NA
Aβ1-42, Week 12n=4 Participants	-78.2	5.08
Aβ1-42, Week 26n=1 Participants	-80.8	NA
PlaceboAβ1-40, Week 12n=12 Participants	1.90	15.0
Aβ1-40, Week 26n=6 Participants	0.944	22.6
Aβ1-42, Week 12n=12 Participants	0.541	10.1
Aβ1-42, Week 26n=6 Participants	1.82	9.98

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations

Time frame:Baseline, 12 weeks, 26 weeks

percent change from baseline, improvement

Secondary/registry result

Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations

Time frame:Baseline, 12 weeks, 26 weeks

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change in tau and ptau-181	Standard error
15 mg LY2886721CSF Tau, Week 12n=7 Participants	14.3	6.06
CSF Ptau, Week 12n=7 Participants	0.7	4.81
35 mg LY2886721CSF Tau, Week 12n=9 Participants	2.6	5.42
CSF Ptau, Week 12n=9 Participants	1.7	4.01
70 mg LY2886721CSF Tau, Week 12n=5 Participants	6.8	7.49
CSF Ptau, Week 12n=5 Participants	4.3	5.41
PlaceboCSF Tau, Week 12n=12 Participants	-4.4	4.63
CSF Ptau, Week 12n=12 Participants	-3.6	3.40

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.