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Study identifier: NCT03828747 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Alzheimer's Disease  ·  Sponsor: Genentech, Inc.

PhasePhase 2
Planned participants272
Who can joinAll sexes, 50 Years to 85 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where49 locations · 4 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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 * 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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (49)

Collaborative Neuroscience Network, Inc.Garden Grove, California, United States
Pharmacology Research InstituteLos Alamitos, California, United States
Stanford University; Stanford Clinical Cancer CtrPalo Alto, California, United States
Pacific Research Network - PRNSan Diego, California, United States
Molecular Neuroimaging; MRI/PETNew Haven, Connecticut, United States
KI Health Partners, LLC; New England Institute for Clinical ResearchStamford, Connecticut, United States
JEM Research LLCAtlantis, Florida, United States
Bradenton Research CenterBradenton, Florida, United States
Brain Matters Research, Inc.Delray Beach, Florida, United States
Neuropsychiatric Research; Center of Southwest FloridaFort Myers, Florida, United States
Miami Jewish Health SystemsMiami, Florida, United States
Collier Neurologic SpecialistsNaples, Florida, United States

+ 37 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

Garden GroveLos AlamitosPalo AltoSan Diego

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