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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224106
First received: October 14, 2010
Last updated: October 20, 2014
Last verified: October 2014

October 14, 2010
October 20, 2014
November 2010
December 2018   (final data collection date for primary outcome measure)
  • Change in the Clinical Dementia Rating scale Sum of Boxes (CDR-SOB), a global measure of cognition and functional ability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Substudy: Change in brain amyloid over time assessed with Positron Emission Tomography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the effect on the change in the Clinical Dementia Rating scale Sum of Boxes (CDR-SOB), a global measure of cognition and functional ability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Substudy: Change in brain amyloid over time assessed with Positron Emission Tomography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01224106 on ClinicalTrials.gov Archive Site
  • Safety (nature and incidence of adverse events) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: gantenerumab levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in functioning assessed with the Functional Activities Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in cognition assessed with the Alzheimer Disease Assessment Scale-Cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Effect on cognition assessed with Alzheimer Disease Assessment Scale-Cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Effect on functioning assessed with Functional Activities Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety (nature and incidence of adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: gantenerumab levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Gantenerumab in Patients With Prodromal Alzheimer's Disease
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for an Additional Two Years of Treatment

This multi-center, randomized, double-blind, placebo-controlled parallel-group s tudy will evaluate the effect of gantenerumab (RO4909832) on cognition and funct ioning and the safety and pharmacokinetics in patients with prodromal Alzheimer' s Disease. Patients will be randomized to receive subcutaneous injections of eit her gantenerumab or placebo. Patients who consent to be part of the sub study wi ll undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks, with an option for an addi tional 2 years of treatment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: gantenerumab
    225 mg subcutaneous doses every 4 weeks for 104 weeks
  • Drug: gantenerumab
    105 mg subcutaneous doses every 4 weeks for 104 weeks
  • Drug: placebo
    subcutaneous doses every 4 weeks for 104 weeks
  • Experimental: 1
    Intervention: Drug: gantenerumab
  • Experimental: 2
    Intervention: Drug: gantenerumab
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Delrieu J, Ousset PJ, Vellas B. Gantenerumab for the treatment of Alzheimer's disease. Expert Opin Biol Ther. 2012 Aug;12(8):1077-86. doi: 10.1517/14712598.2012.688022. Epub 2012 May 15. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
799
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 50-85 years of age
  • Patients with prodromal Alzheimer's Disease who are not receiving memantine or cholinesterase inhibitors
  • Has a study partner who in the investigator's judgement has frequent and sufficient contact with the subject as to be able to provide accurate information as to the patient's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
  • Has had sufficient education or work experience to exclude mental retardation
  • Study partner has noticed a recent gradual decrease in patient's memory (e.g. over the last 12 months), which the patient may or may not be aware of
  • Screening MMSE score of 24 or above

Additional inclusion criteria for sub study:

  • Able and willing to travel to Positron Emission Tomography imaging center and complete the planned scanning sessions
  • Past and planned exposure to ionizing radiation not exceeding safe and permissible levels

Exclusion Criteria:

  • Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
  • A history of stroke
  • A documented history of transient ischemic attack within the last 12 months
  • History of schizophrenia, schizoaffective or bipolar disorder
  • Currently meets criteria for major depression
  • Within the last 2 years, unstable or clinical significant cardiovascular disease (e.g. myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

  • Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months
  • Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203
  • Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   United States,   Argentina,   Australia,   Belgium,   United Kingdom,   Canada,   Chile,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey
 
NCT01224106
WN25203, 2010-019895-66
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP