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RO7105705 for Moderate Alzheimer's Disease

Recruiting

This Phase II trial will evaluate the investigational treatment RO7105705 for people with moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
February 28, 2019
June 3, 2023
260

  • Probable Alzheimer's disease dementia
  • Evidence of the Alzheimer's pathological process, by a positive amyloid assessment as measured through cerebrospinal fluid or positron emission tomography scan
  • Alzheimer's dementia of moderate severity, as defined by a Mini-Mental State Examination score of 16 to 21 points or Clinical Dementia Rating of 1 or 2
  • Study partner who can provide information on the participant's cognitive, behavioral, and functional ability

  • Pregnant or breastfeeding
  • Inability to undergo magnetic resonance imaging (e.g., metal implants or claustrophobia)
  • Inability to undergo positron emission tomography
  • Residence in a skilled nursing facility
  • Serious medical condition or abnormality in laboratory tests that could interfere with safety or study participation
  • Evidence of a condition other than Alzheimer's disease that may affect cognition
  • Substance abuse within the past 2 years
  • Use of experimental therapy within 90 days or 5 half-lives, whichever is greater, or any passive immunotherapy against tau
  • Use of passive immunotherapy (immunoglobulin) against amyloid, unless the last dose was at least 1 year prior, or active immunotherapy (vaccine) to prevent or postpone cognitive decline
  • Other biologic therapy or previous treatment with medications intended to treat Parkinsonian symptoms or other non-Alzheimer's disease neurodegenerative disorder within past year
  • Systemic immunosuppressive therapy within past year and through study period
  • Typical antipsychotic or neuroleptic medication within past 6 months
  • Daily treatment with any of the following (intermittent short-term use is allowed): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or medications with clinically significant centrally-acting antihistamine or anticholinergic activity
  • Stimulant medications, unless the dose has been stable for 6 months and is expected to be stable throughout the study

RO7105705 is an anti-tau antibody that targets a protein involved in the progression of Alzheimer's disease. Participants will be randomly assigned to either the study treatment or placebo. Researchers will measure changes in severity of dementia symptoms and cognitive function, as well as any adverse events and concentrations of the drug at different timepoints.

For more information about this study or study sites, please contact Genentech at 888-662-6728 (U.S. and Canada) or global-roche-genentech-trials@gene.com.

Name City State Zip Status Primary Contact
Collaborative Neuroscience Network, Inc.
Garden Grove California 92845 Completed

Pharmacology Research Institute
Los Alamitos California 90720 Recruiting

Stanford University; Stanford Clinical Cancer Ctr
Palo Alto California 94305 Recruiting

Pacific Research Network - PRN
San Diego California 92103 Active, not recruiting

Molecular Neuroimaging; MRI/PET
New Haven Connecticut 06510 Active, not recruiting

KI Health Partners, LLC; New England Institute for Clinical Research
Stamford Connecticut 06905 Active, not recruiting

JEM Research LLC
Atlantis Florida 33462 Active, not recruiting

Bradenton Research Center
Bradenton Florida 34205 Active, not recruiting

Brain Matters Research, Inc.
Delray Beach Florida 33445 Active, not recruiting

Neuropsychiatric Research; Center of Southwest Florida
Fort Myers Florida 33912 Active, not recruiting

Miami Jewish Health Systems
Miami Florida 33137 Recruiting

Collier Neurologic Specialists
Naples Florida 34105 Active, not recruiting

Accelerated Enrollment Solutions
Orlando Florida 32806 Active, not recruiting

Alzheimer's Research and Treatment Center
Wellington Florida 33414 Active, not recruiting

Premiere Research Institute
West Palm Beach Florida 33407 Active, not recruiting

Rush University Medical Center - Chicago
Chicago Illinois 60612 Recruiting

Alexian Brothers Neuroscience Institute
Elk Grove Village Illinois 60007 Active, not recruiting

Southern Illinois University, School of Medicine
Springfield Illinois 62702 Active, not recruiting

Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
Boston Massachusetts 02115 Active, not recruiting

Alzheimers Disease Center
Quincy Massachusetts 02169 Active, not recruiting

Health Partners Center for Memory and Aging
Saint Paul Minnesota 55130 Active, not recruiting

Advanced Memory Research Institute of NJ
Toms River New Jersey 08755 Recruiting

Empire Neurology PC; MS Center of Northeastern NY
Latham New York 12110 Completed

University of Rochester; AD-CARE
Rochester New York 14642 Active, not recruiting

Summit Research Network Inc.
Portland Oregon 97210 Recruiting

Abington Neurological Associates
Abington Pennsylvania 19001 Active, not recruiting

Rhode Island Mood & Memory Research Institute
East Providence Rhode Island 02914 Active, not recruiting

Butler Hospital; Movement Disorders Program
Providence Rhode Island 02906 Active, not recruiting

Neurology Clinic PC
Cordova Tennessee 38018 Recruiting

New Orleans Center for Clinical Research
Knoxville Tennessee 37920 Active, not recruiting

The Memory Clinic
Bennington Vermont 05201 Completed

Genentech, Inc.

Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche

NCT03828747

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease