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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT03828747

Run by

Genentech, Inc.

People needed

272

Starts

2019-01-25

Expected to finish

2023-08-30

Last updated by the study team

2024-09-24

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Systemic immunosuppressive therapy within 12 months of screening through the entire study period
• Typical antipsychotic or neuroleptic medication within 6 months of screening
• Daily treatment with any of the following classes of medication (except for intermittent short-term use): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity
• Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study

Where it is running

• 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
• Miami Jewish Health Systems — Miami, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Synexus Clinical Research US, Inc. - Orlando — Orlando, Florida, United States
• Alzheimer?s Research and Treatment Center — Wellington, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Rush University Medical Center - Chicago — Chicago, Illinois, United States
• Alexian Brothers Neuroscience Institute — Elk Grove Village, Illinois, United States
• Southern Illinois University, School of Medicine — Springfield, Illinois, United States
• Brigham and Womens Hospital; Center for Alzheimer Research & Treatment — Boston, Massachusetts, United States
• Alzheimers Disease Center — Quincy, Massachusetts, United States
• Center for Memory and Aging — Saint Paul, Minnesota, United States
• Advanced Memory Research Institute of NJ — Toms River, New Jersey, United States
• Empire Neurology PC; MS Center of Northeastern NY — Latham, New York, United States
• University of Rochester; AD-CARE — Rochester, New York, United States
• Summit Research Network Inc. — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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