A Study of Gantenerumab in Participants With Mild Alzheimer Disease



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:2/2/2019
Start Date:March 27, 2014
End Date:November 20, 2020

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
38
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Brooksville, Florida
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1485 Ciudad de La Paz
Ciudad Autonoma de Bs As, C1426AHA
?
mi
from
Ciudad Autonoma de Bs As,
Click here to add this to my saved trials
Cordova, Tennessee 38018
?
mi
from
Cordova, TN
Click here to add this to my saved trials
Costa Mesa, California 92626
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80239
?
mi
from
Denver, CO
Click here to add this to my saved trials
East Providence, Rhode Island 02914
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Lake Worth, Florida 33449
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
Manchester, New Jersey 08759
?
mi
from
Manchester, NJ
Click here to add this to my saved trials
5200 Northeast 2nd Avenue
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
New Orleans, Louisiana 70114
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orangeburg, New York 10962
?
mi
from
Orangeburg, NY
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
220 South River Street
Plains, Pennsylvania 18705
?
mi
from
Plains, PA
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27609
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63132
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
3003 Fourth Avenue
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
Staten Island, New York 10312
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
10515 West Santa Fe Drive
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
The Villages, Florida 32162
?
mi
from
The Villages, FL
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials