A 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:1/16/2019
Start Date:October 20, 2016
End Date:June 29, 2021
Contact:Eisai Medical Information
Email:esi_medinfo@eisai.com
Phone:1-888-274-2378

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A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects With Early Alzheimer's Disease

The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind,
placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's
Disease (EAD) including mild cognitive impairment (MCI) due to Alzheimer's Disease
(AD)/Prodromal AD and the early stages of mild AD will be conducted to evaluate the efficacy
and safety of elenbecestat (proposed international nonproprietary name [INN]) (E2609).


Inclusion Criteria:

- Mild cognitive impairment due to AD or mild AD dementia including

1. Mini Mental State Examination score equal to or greater than 24

2. CDR global score of 0.5

3. CDR Memory Box score of 0.5 or greater

- Impaired episodic memory confirmed by a list learning task

- Positive biomarker for brain amyloid pathology as indicated by either amyloid PET or
CSF assessment or both

- Study partner able to support the participant for duration of the study

- Provide written informed consent. Participants must, in the investigator's judgment,
have the capacity to consent

Exclusion Criteria:

- Females who are breastfeeding or pregnant at Screening or Baseline. Females of
child-bearing potential must use a highly effective method of contraception throughout
the entire study period and for 28 days after study drug discontinuation

- Any condition that may be contributing to cognitive impairment above and beyond that
caused by the participant's AD

- Participants with a history of seizures within 5 years of Screening

- History of transient ischemic attacks or stroke within 12 months of Screening

- Psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, delusions,
etc.)

- Suicidal ideation or any suicidal behavior within 6 months before Screening or has
been hospitalized or treated for suicidal behavior in the past 5 years

- Have any contraindications to magnetic resonance imaging (MRI) scanning or

1. Have lesions that could indicate a dementia diagnosis other than AD on brain MRI

2. Exhibit other significant pathological findings on brain MRI.

- Participants who have a history of moderate to severe hepatic impairment (eg,
Child-Pugh Class B or C)

- Results of laboratory tests conducted during Screening that are outside the following
limits:

1. Absolute lymphocyte count below the lower limit of normal (LLN)

2. Thyroid stimulating hormone above normal range

3. Abnormally low Vitamin B12 levels

- Participants at risk of increased risk of infection

- Have received any live/live attenuated vaccine in the 3 months before randomization

- Any chronic inflammatory disease that is not adequately controlled or that requires
systemic immunosuppressive or immunomodulatory therapy

- Any other clinically significant abnormalities

- Severe visual or hearing impairment

- A prolonged corrected QT (QTc) interval (QTcF greater than 450 milliseconds [ms])

- Malignant neoplasms within 5 years of Screening

- Known or suspected history of drug or alcohol abuse

- Taking prohibited medications, which must be reviewed with the Investigator

- Have participated in a recent clinical study

Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.
We found this trial at
96
sites
401 South Emporia Street
Wichita, Kansas 67214
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1 Center Road
Amherst, New York 14068
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1201 Peachtree Street Northwest
Atlanta, Georgia 30309
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5301 South Congress Avenue
Atlantis, Florida 33462
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1301 East Dean Keeton Street
Austin, Texas 78722
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Aventura, Florida 33187
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Aventura, Florida 33187
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1 Center Street
Bennington, Vermont 05201
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1 Center Plaza
Boston, Massachusetts 02108
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11450 Hagen Ranch Road
Boynton Beach, Florida 33437
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1 MetroTech Center
Brooklyn, New York 11201
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Caba, Buenos Aires
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Caba,
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4863 Fulton Drive Northwest
Canton, Ohio 44718
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1 Elizabeth Place
Centerville, Ohio 45408
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4040 South Arizona Avenue
Chandler, Arizona 85248
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Chesterfield, Missouri 63005
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1 Center Court
Cleveland, Ohio 44115
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Colton, California 92324
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1 Braddock Court
Columbus, Georgia 31907
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Coral Gable, Florida 33134
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1 Andalusia Avenue
Coral Gables, Florida 33134
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1 Andalusia Avenue
Coral Gables, Florida 33134
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381 North Germantown Parkway
Cordova, Tennessee 38018
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1 Center Street
Costa Mesa, California 92626
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350 North Saint Paul Street
Dallas, Texas 75201
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1 South Main Street
Dayton, Ohio 45402
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1 ⛉ West Court Square
Decatur, Georgia 30030
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5859 Heritage Park Way
Delray Beach, Florida 33484
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1 East Center Avenue
Denver, Colorado 80209
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5101 Northwest 79th Avenue
Doral, Florida 33166
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1 Evergreen Drive
East Providence, Rhode Island 02914
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2 Delta Drive
East Providence, Rhode Island 02860
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30415 Shiawassee Street
Farmington Hills, Michigan 48336
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101 East Valencia Mesa Drive
Fullerton, California 92835
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Hampton, Virginia 23666
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3553 West 76th Street
Hialeah, Florida 33018
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909 Fannin Street
Houston, Texas 77010
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Imperial, California 92251
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1 Burroughs
Irvine, California 92618
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440 York Road
Jenkintown, Pennsylvania 19046
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1324 Hird Avenue
Lakewood, Ohio 44107
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Lemon Grove, California 91945
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1 Plant Street
Lincoln, Rhode Island 02864
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1 John Nolen Drive
Madison, Wisconsin 53705
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6000 Pennell Road
Media, Pennsylvania 19063
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1353 West 1st Street
Meridian, Idaho 83642
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701 Northwest 57th Avenue
Miami, Florida 33126
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8 State Highway 9
Miami, Florida 33125
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701 Northwest 57th Avenue
Miami, Florida 33126
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4 Grove Isle Drive
Miami, Florida 33133
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833 Southwest 29th Avenue
Miami, Florida 33135
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1250 Southwest 108th Avenue
Miami, Florida 33174
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6220 South Dixie Highway
Miami, Florida 33144
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1540 Northwest 111th Street
Miami, Florida 33167
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8720 Southwest 9th Terrace
Miami, Florida 33174
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10343 Southwest 124th Street
Miami, Florida 33176
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2 Hillside Drive
Mount Arlington, New Jersey 07856
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3102 West End Avenue
Nashville, Tennessee 37203
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1027 18th Avenue South
Nashville, Tennessee 37212
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1 Center Drive
New York, New York 11357
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1368 Shermer Road
Northbrook, Illinois 60062
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2770 State Highway K
O'Fallon, Missouri 63368
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3040 Oceanside Boulevard
Oceanside, California 92054
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4171 Oceanside Boulevard
Oceanside, California 92056
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1 Greenfield Center Drive
Oklahoma City, Oklahoma 73127
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Orlando, Florida 32801
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315 East Robinson Street
Orlando, Florida 32801
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Orlando, Florida 32807
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Oxnard, California
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4404 Burns Road
Palm Beach Gardens, Florida 33410
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Panorama City, California 91402
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9880 Bustleton Avenue
Philadelphia, Pennsylvania 19115
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Pompano Beach, Florida 33064
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4033 Beaver Lane
Port Charlotte, Florida 33952
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Port Orange, Florida 32127
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1 Port Royal Landing Drive
Port Royal, South Carolina 29935
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1 North Center Court Street
Portland, Oregon 97227
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1 Butler Avenue
Providence, Rhode Island 02906
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825 Jadwin Avenue
Richland, Washington 99352
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2 South County Center Way
Saint Louis, Missouri 63129
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12837 Flushing Meadows Drive
Saint Louis, Missouri 63131
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1 South County Center Way
Saint Louis, Missouri 63129
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Saint Peters, Missouri 63303
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501 Chipeta Way
Salt Lake City, Utah 84108
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1 Heartland Drive
San Antonio, Texas 78247
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17720 Corporate Woods Drive
San Antonio, Texas 78259
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San Diego, California 92126
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Spring Hill, Florida 34609
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65 Springfield Avenue
Springfield, New Jersey 07081
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3900 McGinnis Ferry Road
Suwanee, Georgia 30024
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3122 West Sligh Avenue
Tampa, Florida 33614
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201 North Franklin Street
Tampa, Florida 33602
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2478 Burnsed Boulevard
The Villages, Florida 32163
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290 New Jersey 36
West Long Branch, New Jersey 07764
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Westerville, Ohio 43081
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Yorba Linda, California 92886
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