LY3372993 for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- be 55 to 80 years old"}
• {"criterion_text":"- have a reliable study partner"}
• {"criterion_text":"- have a screening biomarker blood test result that points to the presence of plaques in the brain"}
• {"criterion_text":"- have no or only mild problems with memory and function"}

Exclusion criteria

• {"criterion_text":"- have dementia or other significant disease of the brain that affects memory and thinking"}
• {"criterion_text":"- have a current serious medical condition or abnormality that could increase the risk to their safety or could interfere with the results of this study"}
• {"criterion_text":"- have a history of severe drug allergies or hypersensitivity reactions"}
• {"criterion_text":"- have certain health conditions that prevent them from getting an MRI"}
• {"criterion_text":"- have had recent treatment with a drug to remove plaque from the brain"}

Primary endpoints

• {"endpoint_text":"- Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR). CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).","definition_or_measurement_approach":"CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD)."}

Methods

• Letter to doctors / referrals (document: K2_LAKI_Letter-Doctor-Referral_Master)
• Printed outreach materials: posters, flyers, trial brochures (documents: K2_LAKI_Poster_Master; K2_LAKI_Flyer_Master; K2_LAKI_Trial-Brochure_Master)
• Study-partner focused materials / info-cards (document: K2_LAKI_Info-Card-Study-Partner_Master)
• Inclusion/exclusion summary cards for site use (documents: K2_LAKI_Inclusion-Exclusion-Cards_Redacted; K2_LAKI_Inclusion-Exclusion-Cards-OUS_Redacted)
• Use of patient-facing recruitment materials and information about Alzheimer's brain changes (documents: K2_Neuro_AD_Alzheimers-Brain-Changes; K2_LAKI_Trial-Brochure_Master_Redacted). All materials are listed for the Spain part II submission.

Spain

Earliest CTIS Part Ii Submission Date

19-02-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

439

Number Of Sites

7

Number Of Participants

43

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Charles River Laboratories, Inc.

Responsibilities

code:4

Name

Clinical Ink Inc.

Responsibilities

code:7

Name

Bioclinica Inc.

Responsibilities

imaging

Name

Labcorp Central Laboratory Services SARL

Responsibilities

code:4

Name

Iqvia Rds Inc.

Responsibilities

code:1

Name

Bioagilytix Labs LLC

Responsibilities

code:4

Name

Cogstate Inc.

Responsibilities

Central rating

Name

RWS Life Sciences Inc.

Responsibilities

Translation

Name

Greenphire LLC

Responsibilities

code:2

Third parties

• {"country":"Canada","full_name":"Charles River Laboratories, Inc.","duties_or_roles":"code:4","organisation_type":"Health care"}
• {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"code:2","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Translation","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Cogstate Inc.","duties_or_roles":"Central rating","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}