NCT01561430|TerminatedPhase 1Results

Study Stopped

Study terminated due to abnormal liver biochemical tests in some participants.

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

Eli Lilly and Company ClinicalTrials.gov

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3 other identifiers

13735I4O-MC-BACC2011-005217-37

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredMar 2012

StartedMar 2012

CompletionAug 2013

Brief Summary

The purpose of this Phase 1/Phase 2 study is to evaluate how the body handles the drug and the drug's effect on the body of participants with mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD and who test positive for amyloid plaque.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Mar 2012

Geographic Reach

5 countries

34 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

March 1, 2012

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed

4.8 years until next milestone

Results Posted

Study results publicly available

May 18, 2018

Completed

Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

March 21, 2012

Results QC Date

March 24, 2018

Last Update Submit

May 16, 2018

Conditions

Alzheimer's Disease

Keywords

beta-secretase inhibitor

Outcome Measures

Primary Outcomes (2)

Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.
Baseline, 12 weeks
Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations
Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 26 weeks post-dose was to be calculated. The units for CSF were picograms per milliliter (pg/mL). LS means of percent change in concentration from baseline was calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.
Baseline, 26 weeks

Secondary Outcomes (6)

Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Baseline, 12 weeks, 26 weeks
Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)
Baseline, 26 weeks
Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Baseline, 26 weeks
Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Baseline, 26 weeks
Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)
Baseline, 26 weeks
+1 more secondary outcomes

Study Arms (4)

15 mg LY2886721

EXPERIMENTAL

LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.

Drug: LY2886721

35 mg LY2886721

EXPERIMENTAL

LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.

Drug: LY2886721

70 mg LY2886721

EXPERIMENTAL

LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.

Drug: LY2886721

Placebo

PLACEBO COMPARATOR

Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.

Drug: Placebo

Interventions

LY2886721DRUG

15 mg LY288672135 mg LY288672170 mg LY2886721

PlaceboDRUG

Placebo

Eligibility Criteria

Age55 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (34)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Phoenix, Arizona, 85006, United States

Location

Sun City, Arizona, 85351, United States

Location

Tucson, Arizona, 85741, United States

Location

Long Beach, California, 90806, United States

Location

San Francisco, California, 94109, United States

Location

Denver, Colorado, 80239, United States

Location

New Haven, Connecticut, 06510, United States

Location

Boca Raton, Florida, 33486, United States

Location

Delray Beach, Florida, 33445, United States

Location

Fort Myers, Florida, 33912, United States

Location

Ocala, Florida, 34471, United States

Location

Orlando, Florida, 32806, United States

Location

West Palm Beach, Florida, 33407, United States

Location

Decatur, Georgia, 30033, United States

Location

Chicago, Illinois, 60612, United States

Location

Lexington, Kentucky, 40504, United States

Location

Plymouth, Massachusetts, 02360, United States

Location

Quincy, Massachusetts, 02169, United States

Location

Monroe, New Jersey, 08831, United States

Location

Albany, New York, 12206, United States

Location

Durham, North Carolina, 27705, United States

Location

Dayton, Ohio, 45408, United States

Location

Portland, Oregon, 97210, United States

Location

Salt Lake City, Utah, 84106, United States

Location

Biella, 13900, Italy

Location

Pisa, 56126, Italy

Location

Rome, 00179, Italy

Location

Osaka, 545-8586, Japan

Location

Tokyo, 113, Japan

Location

Amsterdam, 1081 GM, Netherlands

Location

Barcelona, 08014, Spain

Location

Getafe, 28905, Spain

Location

Madrid, 28040, Spain

Location

Sant Cugal Del Valles, 08195, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

N-(3-(2-amino-4a,5,7,7a-tetrahydro-4H-furo(3,4-d)(1,3)thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Limitations and Caveats

Study was terminated early because of abnormal liver biochemical tests levels for 4 participants.

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 18, 2018

Results First Posted

May 18, 2018

Record last verified: 2018-05

Locations

ES(4)US(24)IT(3)JP(2)NL(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (4)

15 mg LY2886721

35 mg LY2886721

70 mg LY2886721

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations