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:2/6/2019
Start Date:December 29, 2016
End Date:June 22, 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 MissionAD2. 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 [pINN]) (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
87
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Aventura, Florida 33187
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1 Center Street
Albany, New York 12204
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7649 Airline Highway
Baton Rouge, Louisiana 70808
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Beachwood, Ohio 44122
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17701 Ibbetson Avenue
Bellflower, California 90706
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1 Center Circle Drive
Bradenton, Florida 34207
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301 South College Street
Charlotte, North Carolina 28202
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5151 Sardis Road
Charlotte, North Carolina 28270
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Chatham, Ontario
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6840 North Sacramento Avenue
Chicago, Illinois 60645
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Creve Coeur, Missouri 63141
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350 North Saint Paul Street
Dallas, Texas 75201
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1 ⛉ West Court Square
Decatur, Georgia 30030
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1008 Springbrook Drive
DeSoto, Texas 75115
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5101 Northwest 79th Avenue
Doral, Florida 33166
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Elk Grove Village, Illinois
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1400 North Gilbert Road
Gilbert, Arizona 85234
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3600 Ocean View Boulevard
Glendale, California 91206
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Glens Falls, New York 12801
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3590 Stanford Street
Greenville, Texas 75401
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Greenville, Texas 75401
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Hattiesburg, Mississippi 39401
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3553 West 76th Street
Hialeah, Florida 33018
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Hialeah, Florida 33012
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909 Fannin Street
Houston, Texas 77010
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1 Burroughs
Irvine, California 92618
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7740 Point Meadows Drive
Jacksonville, Florida 32256
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Knoxville, Tennessee 37996
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22992 El Pacifico Drive
Laguna Hills, California 92653
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4343 10th Avenue North
Lake Worth, Florida 33461
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3083 West Lake Mead Boulevard
Las Vegas, Nevada 89032
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1 Chenal Heights Drive
Little Rock, Arkansas 72223
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1 Center Way
Lomita, California 90503
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Long Beach, California 90815
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1 Center Way
Los Angeles, California 90045
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Maitland, Florida 32701
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30 Park Avenue
Manhasset, New York 11030
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2200 Heritage Parkway
Mansfield, Texas 76063
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Medford, Oregon 97504
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6400 North US Highway 1
Melbourne, Florida 32940
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701 Northwest 57th Avenue
Miami, Florida 33126
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701 Northwest 57th Avenue
Miami, Florida 33126
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8720 Southwest 9th Terrace
Miami, Florida 33174
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4 Grove Isle Drive
Miami, Florida 33133
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6220 South Dixie Highway
Miami, Florida 33144
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833 Southwest 29th Avenue
Miami, Florida 33135
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1540 Northwest 111th Street
Miami, Florida 33167
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1250 Southwest 108th Avenue
Miami, Florida 33174
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10343 Southwest 124th Street
Miami, Florida 33176
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8 State Highway 9
Miami, Florida 33125
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5780 Northwest 158th Street
Miami Lakes, Florida 33014
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201 Curtiss Parkway
Miami Springs, Florida 33166
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New Haven, Connecticut 06510
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Newnan, Georgia 30265
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530 Church St
Norristown, Pennsylvania 19401
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North Miami, Florida 33161
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Ocala, Florida 34470
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Oceanside, California 92054
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Oklahoma City, Oklahoma 73127
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202 Strawberry Oaks Drive
Orange City, Florida 32763
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Orlando, Florida 32801
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17171 South Dixie Highway
Palmetto Bay, Florida 33157
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2701 El Camino Real
Palo Alto, California 94306
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Pembroke Pines, Florida 33024
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Phoenix, Arizona 85004
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Pinellas Park, Florida 33782
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Plains, Pennsylvania 18705
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Plymouth, Massachusetts 02360
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Portland, Oregon 97227
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9101 Bon Air Crossings Drive
Richmond, Virginia 23235
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Richmond, Virginia 23224
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Riverside, California 92506
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100 2nd Avenue North
Saint Petersburg, Florida 33701
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501 Chipeta Way
Salt Lake City, Utah 84108
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Santa Ana, California 92704
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Santa Ana, California 92705
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Santa Monica, California 90405
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Schaumburg, Illinois 60194
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Scottsdale, Arizona 85258
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Stamford, Connecticut 06905
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Toms River, New Jersey 08753
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Toms River, New Jersey 08755
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8912 2700 West
West Jordan, Utah 84088
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West Palm Beach, Florida 33407
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Wichita, Kansas 67219
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121 Franklin Place
Woodmere, New York 11598
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