A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Stopped early · Phase 2
Conditions studied: Alzheimer Disease
In brief
This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.
Key facts
- Study ID
- NCT04592341
- Run by
- Hoffmann-La Roche
- People needed
- 192
- Starts
- 2020-11-18
- Expected to finish
- 2023-03-15
- Last updated by the study team
- 2024-03-27
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Probable Alzheimer's Disease (AD) dementia or prodromal AD.
- Availability of a reliable study partner (non-professional caregiver) who accepts to participate in study procedure throughout the study duration
- The participant should be capable of completing all aspects of study assessments including MRI, clinical genotyping, and PET imaging, either alone or with the help of the study partner (non-professional caregiver).
- Adequate visual and auditory acuitysufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted).
- Evidence of AD pathological process, as confirmed by amyloid PET scan by qualitative read by the core/central PET laboratory.
- Prodromal or mild symptomatology, as defined by a screening Mini-Mental State Examination (MMSE) score >/=22 and Clinical Dementia Rating global score (CDR-GS) of 0.5 or 1.0, as well as a clinical dementia rating (CDR) memory domain score >/=0.5.
- If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 3 months prior to screening and until start of study treatment.
- Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug.
- Agreement not to participate in other research studies for the duration of this trial, unless these are related Roche-sponsored non-interventional studies.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods hat result in a failure rate of < 1% per year during the treatment period and for at least 16 weeks after the final dose of study drug.
You may not qualify if…
- Any evidence of a condition other than AD that may affect cognition.
- History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function.
- History or presence of clinically evident cerebrovascular disease.
- History or presence of posterior reversible encephalopathy syndrome.
- History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack.
- History of severe, clinically significant CNS trauma.
- History or presence of intracranial mass that could potentially impair cognition.
- Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae.
- History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits.
- History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder.
- At risk for suicide in the opinion of the investigator.
- Alcohol and/or substance abuse or dependants in past 2 years.
Where it is running
- JEM Research LLC — Atlantis, Florida, United States
- ClinCloud, LLC — Maitland, Florida, United States
- Renstar Medical Research — Ocala, Florida, United States
- Alzheimer?s Research and Treatment Center — Wellington, Florida, United States
- Center for Advanced Research & Education — Gainesville, Georgia, United States
- Summit Research Network Inc. — Portland, Oregon, United States
- Abington Neurological Associates Willow Grove — Willow Grove, Pennsylvania, United States
- Jessa Zkh (Campus Virga Jesse) — Hasselt, Belgium
- AZ Groeninge — Kortrijk, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502) — Bron, France
- CH Pitie Salpetriere; IM2A — Paris, France
- Gerontopole; Centre de Recherche clinique — Toulouse, France
- Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin — Berlin, Germany
- ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic — Berlin, Germany
- Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie — München, Germany
- Ospedale Cardinale Panico; Dip.Ricerca Clinica in Neurologia ? UO Malattie Neurodegenerative — Tricase (LE), Apulia, Italy
- Ospedale San Giovanni Calibita Fatebenefratell;Neurologia — Rome, Lazio, Italy
- Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia — Milan, Lombardy, Italy
- NZOZ Vitamed — Bydgoszcz, Poland
- Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. — Lublin, Poland
- Senior Sp. Z O.O. Poradnia Psychogeriatryczna — Sopot, Poland
- Centrum Medyczne Euromedis Sp. z o.o. — Szczecin, Poland
- Centrum Medyczne NeuroProtect — Warsaw, Poland
- NZOZ WCA — Wroc?aw, Poland
Full record on ClinicalTrials.gov
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