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A Study of Semorinemab in Patients With Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Semorinemab in Patients With Moderate Alzheimer's Disease

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease

NCT03828747•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to two study cohorts.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•National Institute on Aging/Alzheimer's Association core clinical criteria for probable AD dementia
•Evidence of the AD pathological process, by a positive amyloid assessment either on CSF Aβ1-42 as measured on Elecsys β-Amyloid(1-42) Test System OR amyloid PET scan
•AD dementia of moderate severity, as defined by a screening MMSE score of 16-21 points, inclusive, and a CDR-GS of 1 or 2
•Availability of a person with sufficient contact with the participant to be able to provide accurate information on the participant's cognitive, behavioral and functional ability

Exclusion Criteria

•Pregnant or breastfeeding
•Inability to tolerate MRI procedures or contraindication to MRI
•Contraindication to PET imaging
•Residence in a skilled nursing facility
•Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree
•Any evidence of a condition other than AD that may affect cognition
•Substance abuse within the past 2 years
•Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau
•Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was at least 1 year prior to screening or any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
•Any other biologic therapy or previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other non-AD neurodegenerative disorder within 1 year of screening
+4 more criteria

Locations (49)

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Stanford University; Stanford Clinical Cancer Ctr

Palo Alto, California, United States

Pacific Research Network - PRN

San Diego, California, United States

Molecular Neuroimaging; MRI/PET

New Haven, Connecticut, United States

KI Health Partners, LLC; New England Institute for Clinical Research

Stamford, Connecticut, United States

JEM Research LLC

Atlantis, Florida, United States

Bradenton Research Center

Bradenton, Florida, United States

Brain Matters Research, Inc.

Delray Beach, Florida, United States

Neuropsychiatric Research; Center of Southwest Florida

Fort Myers, Florida, United States

Key Dates

Start Date

January 25, 2019

Primary Completion Date

July 20, 2021

Completion Date

August 30, 2023

Last Updated

September 24, 2024

Enrollment

272

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Semorinemab

DRUG

Placebo

DRUG

[18F]GTP1

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Semorinemab in Patients With Moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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