Eine Studie zu Gantenerumab bei Teilnehmenden mit leichter Alzheimer-Krankheit

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

  • Neurodegenerative Erkrankung
  • Alzheimer-Krankheit (AK)
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:

Abgeschlossen

Diese Studie läuft in
Städte
  • Berlin
  • Leipzig
  • Mittweida
  • München
  • Ulm
  • Westerstede
Studien-ID:

NCT02051608 2013-003390-95 WN28745

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02051608, WN28745, 2013-003390-95 Studien-ID
      Gantenerumab, Placebo Treatments
      Alzheimer's Disease Condition
      Official Title

      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

      Einschlusskriterien

      All Gender
      ≥50 Years & ≤ 90 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication
      • Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology
      • Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities
      • Fluency in the language of the tests used at the study site
      • Willingness and ability to complete all aspects of the study
      • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
      • If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
      • Agreement not to participate in other research studies for the duration of this trial and its associated substudies

      PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2

      Exclusion Criteria
      • Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
      • History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
      • History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
      • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
      • History of schizophrenia, schizoaffective disorder, or bipolar disorder
      • Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
      • History or presence of atrial fibrillation
      • Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
      • Uncontrolled hypertension
      • Chronic kidney disease
      • Impaired hepatic function

      PET imaging substudy, in addition to above:

        - Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits

      Part 2 Participants who have been discontinued from the study

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