A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT01224106
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Gantenerumab — DRUG
    Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.
  • Placebo — DRUG
    Participants received Placebo SC injection Q4W.

Study Details

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020. The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.

Key Dates

Start date
Nov 30, 2010
Status verified
Dec 2021
Primary completion
Sep 10, 2020
Completion
Sep 10, 2020

Study Design

Enrollment
799 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo (Parts 1 and 2)
    Participants with Alzheimer's disease received Placebo by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
  • Experimental: Gantenerumab 105 mg (Parts 1 and 2)
    Participants with Alzheimer's disease received Gantenerumab 105 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
  • Experimental: Gantenerumab 225 mg (Parts 1 and 2)
    Participants with Alzheimer's disease received Gantenerumab 225 mg by SC injection every 4 weeks (Q4W) for 104 weeks or approximately 2 years during Part 1 of the study. Participants who completed the Week 104 visit were given an option to continue the treatment received during Part 1, for 2 additional years in Part 2.
  • Placebo Comparator: Placebo (Parts 1 and 2) switched to Gantenerumab Up to 1200mg (Part 3 Open-Label Extension [OLE])
    Participants with Alzheimer's disease who had received Placebo by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.
  • Experimental: Gantenerumab Up to 1200 mg (Part 3 Open-Label Extension [OLE])
    Participants with Alzheimer's disease who had received Gantenerumab by SC injection in Part 1 or Part 2, now received Gantenerumab at doses up to 1200 mg by SC injection every 4 weeks (Q4W) for up to 5 additional years.

Primary Outcome Measure

Mean Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Total Score at Week 104 (Double-Blind Treatment Phase) [ Time Frame: Baseline, Week 104 ]

Locations (24)

FacilityCityStateZIPSite coordinators
Banner Alzheimer's InstitutePhoenixArizona85006-
University of California, San DiegoLa JollaCalifornia92037-
Yale University ADRUNew HavenConnecticut06510-
Brain Matters Research, Inc.Delray BeachFlorida33445-
Infinity Clinical ResearchHollywoodFlorida33024-
Accelerated Enrollment SolutionsOrlandoFlorida32806-
Roskamp Institute, Inc.SarasotaFlorida34243-
Compass ResearchThe VillagesFlorida32162-
Premiere Research InstituteWest Palm BeachFlorida33407-
Indiana UniversityIndianapolisIndiana46202-
Boston Center for MemoryNewtonMassachusetts02459-
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical ResearchKalamazooMichigan49008-
Neurological Research CenterHattiesburgMississippi39401-
Princeton Medical InstitutePrincetonNew Jersey08540-
Nathan Kline InstituteOrangeburgNew York10962-
University of Rochester Medical Center; Monroe Community HospitalRochesterNew York14627-
Alzheimer's Memory CenterMatthewsNorth Carolina28105-
Oregon Health and Science University, Layton Aging and Alzheimer's Disease CenterPortlandOregon97239-
Northeastern Pennsylvania MemoryPlainsPennsylvania18705-
Rhode Island Mood & Memory Research InstituteEast ProvidenceRhode Island02914-
Butler HospitalProvidenceRhode Island02906-
Senior Adults Specialty ResearchAustinTexas78757-
Texas Neurology PADallasTexas75206-
Clinical Neuroscience Research Associates, Inc.BenningtonVermont05201-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Banner Alzheimer's Institute· Phoenix, AZUniversity of California, San Diego· La Jolla, CAYale University ADRU· New Haven, CTBrain Matters Research, Inc.· Delray Beach, FLInfinity Clinical Research· Hollywood, FLAccelerated Enrollment Solutions· Orlando, FL

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