Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease

Official Summary

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).

Eligibility Requirements

• Minimum Age: 60 Years
• Maximum Age: 85 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 1,667 participants

Study Arms

• Remternetug (IV) (EXPERIMENTAL)
  Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
• Remternetug (SC) (EXPERIMENTAL)
  Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
• Placebo (PLACEBO_COMPARATOR)
  Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
• Open-Label Addenda Remternetug (IV) (EXPERIMENTAL)
  Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.
• Open-Label Addenda Remternetug (SC) (EXPERIMENTAL)
  Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.

Interventions

• DRUG: Remternetug (IV) — Administered IV
• DRUG: Remternetug (SC) — Administered SC
• DRUG: Placebo — Administered IV or SC

Primary Outcomes

• Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo (Week 52)

Secondary Outcomes

• Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo (Baseline, Week 52)
• Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo (Week 24)
• Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo (Baseline, Week 24)
• Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo (Up to Week 52)
• Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug (Baseline to Week 52)

Eligibility Criteria

Inclusion Criteria:

* Gradual and progressive change in cognitive function ≥6 months prior to screening.
* A Mini-Mental (MMSE) score of 20 to 30 (inclusive) at screening.
* Has an amyloid PET scan result consistent with the eligibility criteria.
* Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
* Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
* Males and females will be eligible for this study.
* Women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion Criteria:

* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of \<24 months.
* History of cancer with high risk of recurrence and preventing completion of the trial.
* Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.
* History of clinically significant multiple or severe drug allergies.
* Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.
* Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
* Have any contraindications for MRI or positron emission tomography (PET).
* Have had prior treatment with a passive anti-amyloid immunotherapy.
* Have received active immunization against Aβ in any other study.
* Have known allergies to remternetug related compounds, or any components of the formulation.

Trial Locations

• MD First Research - Chandler, Chandler, Arizona, United States
• Hope Clinical Research, Inc., Canoga Park, California, United States
• North County Neurology Associates, Carlsbad, California, United States
• Wr- Pri, Llc, Encino, California, United States
• Neuro-Pain Medical Center, Fresno, California, United States
• Irvine Clinical Research, Irvine, California, United States
• Kaizen Brain Center, La Jolla, California, United States
• Anderson Clinical Research, Redlands, California, United States
• Mountain Neurological Research Center, Basalt, Colorado, United States
• Alpine Clinical Research Center, Boulder, Colorado, United States
• ...and 10 more locations

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) — STUDY_DIRECTOR
  Eli Lilly and Company

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