A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 80
Updated:3/22/2019
Start Date:October 4, 2017
End Date:September 20, 2022
Contact:Reference Study ID: GN39763 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. only)

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

This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the
efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's disease.
An optional 96-week open-label extension period will be available to participants who
complete the double-blind treatment period and who, in the judgment of the investigator,
would potentially benefit from open-label RO7105705 treatment.


Inclusion criteria

- Age between 50 and 80 years

- National Institute on Aging/Alzheimer's Association core clinical criteria for
probable Alzheimer's disease (AD) dementia or mild cognitive impairment (prodromal AD)

- Evidence of the AD pathological process, by a positive amyloid assessment either on
cerebrospinal fluid Aβ1−42 OR amyloid positron emission tomography (PET) scan.
Historical amyloid PET scans may be accepted in some cases

- Mild AD symptomatology, as defined by a screening Mini-Mental State Examination score
of >= 20 points and Clinical Dementia Rating (CDR) −Global Score of 0.5 or 1

- Abnormal memory function at screening

- Availability of a person with sufficient contact with the participant to be able to
provide accurate information on the participant's cognitive and functional ability

Exclusion criteria

- Pregnant or breastfeeding

- Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication
to MRI

- Contraindications to both PET imaging and lumbar dural puncture (must be able to
undergo at least one of these procedures to be eligible)

- Residence in a skilled nursing facility

- Any serious medical condition or abnormality in clinical laboratory tests that remains
abnormal on retest and, in the investigator's judgment, precludes the patient's safe
participation in and completion of the study, or bias the assessment of the clinical
or mental status of the participant to a significant degree

- Any evidence of a condition other than AD that may affect cognition

- Alcohol or substance abuse within the past 2 years

- Use of any experimental therapy within 90 days or 5 half-lives prior to screening,
whichever is greater and any passive immunotherapy (immunoglobulin) against tau,
except use of RO7105705 in Genentech Study GN39058, as long as the last dose was at
least 90 days prior to screening

- Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was
at least 1 year prior to screening and any active immunotherapy (vaccine) that is
under evaluation to prevent or postpone cognitive decline

- Any previous treatment with medications specifically intended to treat Parkinsonian
symptoms or any other neurodegenerative disorder within 1 year of screening

- Systemic immunosuppressive therapy within 12 months of screening through the entire
study period

- Typical antipsychotic or neuroleptic medication within 6 months of screening

- Daily treatment with any of the following classes of medication, except for
intermittent short-term use, which is permitted except within 2 days or 5 half-lives
(whichever is longer) prior to any COA: atypical antipsychotics, opiates or opioids,
benzodiazepines, barbiturates, hypnotics, or any medication with clinically
significant centrally-acting antihistamine or anticholinergic activity

- Stimulant medications, unless the dose has been stable within the 6 months prior to
screening and is expected to be stable throughout the study
We found this trial at
47
sites
489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3924 9th Avenue West
Bradenton, Florida 34205
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3212 Cove Bend Drive
Tampa, Florida 33613
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47 New Scotland Avenue
Albany, New York 12208
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1518 Clifton Road
Atlanta, Georgia 30322
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Atlantis, Florida 33462
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777 Glades Road
Boca Raton, Florida 33431
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350 Longwood Avenue
Boston, Massachusetts 02115
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1750 West Harrison Street
Chicago, Illinois 60612
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Cordova, Tennessee 38018
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438 Victoria Street
Darlinghurst, New South Wales 2010
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Delray Beach, Florida 33445
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East Providence, Rhode Island 02914
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Elk Grove Village, Illinois 60007
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Fort Myers, FL
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Glendale, California 91206
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Knoxville, Tennessee 37920
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Lake Worth, Florida 33449
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1182 Troy Schenectady Road
Latham, New York 12110
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Miami, Florida 33137
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Mount Arlington, New Jersey 07856
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Naples, Florida 34102
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New Haven, Connecticut
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1601 Dove Street
Newport Beach, California 92660
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100 West Gore Street
Orlando, Florida 32806
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1701 Solar Drive
Oxnard, California 93030
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213 Quarry Road
Palo Alto, California 94304
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Portland, Oregon 97210
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Quincy, Massachusetts 02169
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601 Elmwood Avenue
Rochester, New York 14642
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295 Phalen Boulevard
Saint Paul, Minnesota 55130
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3003 Fourth Avenue
San Diego, California 92103
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San Francisco, California 94115
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11600 Wilshire Boulevard
Santa Monica, California 90025
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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Toms River, New Jersey 08757
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Torrance, California 90502
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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West Palm Beach, Florida 33407
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Willow Grove, Pennsylvania 19090
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