Phase
Condition
Alzheimer's Disease
Memory Loss
Mental Disability
Treatment
N/AClinical Study ID
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of prodromal AD, including the following:
History of subjective memory decline with gradual onset and slow progression forat least one year corroborated by an informant,
Objective impairment in episodic memory by memory test performed at Screening,
Does not meet criteria for dementia, AND
Positive Screening amyloid imaging PET scan using [18F]flutametamol tracer orpositive Screening CSF tau:amyloid─β42 (Aβ42) ratio (Participants with a priorpositive amyloid imaging PET scan or a Screening PET scan with florbetaben orflorbetapir may be enrolled without a Screening flutemetamol scan with Sponsorapproval)
Able to read at a 6th grade level or equivalent
If participant is receiving an acetylcholinesterase inhibitor or memantine, the dosemust have been stable for at least three months before Screening
Must have a reliable and competent trial partner/informant who has a closerelationship with the participant and is willing to accompany the participant to allrequired trial visits, and to monitor compliance of the administration of the trialmedication Inclusion Criteria for Extension Period (Part 2):
Tolerated study drug and completed the initial 104─week period of the trial (Part 1)
Participant must have a reliable and competent trial partner who must have a closerelationship with the subject
Exclusion
Exclusion Criteria:
History of stroke
Evidence of a clinically relevant neurological disorder other than the disease beingstudied (i.e., prodromal AD)
History of seizures or epilepsy within the last 5 years
Evidence of a clinically relevant or unstable psychiatric disorder, excluding majordepression in remission
Participant is at imminent risk of self─harm or of harm to others
History of alcoholism or drug dependency/abuse within the last 5 years beforeScreening
Participant does not have a magnetic resonance imaging (MRI) scan obtained within 12months of Screening and is unwilling or not eligible to undergo an MRI scan at theScreening Visit. With Sponsor approval, a head computed tomography (CT) scan may besubstituted for MRI scan to evaluate eligibility
History of hepatitis or liver disease that has been active within the 6 months priorto Screening
Recent or ongoing, uncontrolled, clinically significant medical condition within 3months of Screening
History of malignancy occurring within the 5 years before Screening, except foradequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,or localized prostate carcinoma
Clinically significant vitamin B12 or folate deficiency in the 6 months beforeScreening
Use of any investigational drugs or participation in clinical trials within the 30days before Screening
History of a hypersensitivity reaction to more than three drugs
Has human immunodeficiency virus (HIV) by medical history
Participant is unwilling or has a contraindication to undergo PET scanning includingbut not limited to claustrophobia, excessive weight or girth
History or current evidence of long QT syndrome, corrected QT (QTc) interval ≥470milliseconds (for male participants) or ≥480 milliseconds (for female participants),or torsades de pointes
Close family member (including the trial partner, spouse or children) who is among thepersonnel of the investigational or sponsor staff directly involved with this trial Exclusion Criteria for Extension Period (Part 2):
Participant is at imminent risk of self─harm or of harm to others
Has developed a recent or ongoing, uncontrolled, clinically significant medical orpsychiatric condition
Results of safety assessments (e.g., laboratory tests) performed in participant at endof Part 1 that are clinically unacceptable to the Investigator
Has developed a form of dementia that is not AD
Has progressed to dementia due to AD per investigator diagnosis in the initial 104─week study (Part 1). Exclusion Criteria for NFT PET Substudy (Part 2):
Had one or two PET scans with MK─6240 in the initial 104─week study.
Study Design
Study Description
Connect with a study center
Merck Sharp & Dohme (Argentina) Inc.
Buenos Aires,
ArgentinaSite Not Available
Merck Sharp & Dohme
North Ryde,
AustraliaSite Not Available
MSD Osterreich GmbH
Vienna,
AustriaSite Not Available
MSD Belgium BVBA/SPRL
Brussels,
BelgiumSite Not Available
MSD Brasil
Sao Paulo,
BrazilSite Not Available
Merck Canada
Kirkland, Quebec H9H 3L1
CanadaSite Not Available
MSD Finland Oy
Espoo,
FinlandSite Not Available
MSD France
Paris,
FranceSite Not Available
MSD Sharp & Dohme GmbH
Haar,
GermanySite Not Available
MSD Pharma Hungary Kft.
Budapest,
HungarySite Not Available
MSD Ireland (Human Health) Ltd.
Dublin,
IrelandSite Not Available
MSD Italia S.r.l.
Rome,
ItalySite Not Available
MSD K.K.
Chiyoda-Ku, Tokyo, 102-8667
JapanSite Not Available
MSD Korea LTD
Seoul,
Korea, Republic ofSite Not Available
Merck Sharp & Dohme BV
Haarlem,
NetherlandsSite Not Available
Merck Sharp & Dohme (New Zealand) Ltd.,
Wellington,
New ZealandSite Not Available
MSD Norge A/S
Drammen,
NorwaySite Not Available
MSD Polska Sp. Z o.o.
Warsaw,
PolandSite Not Available
Merck Sharp and Dohme de Espana S.A.
Madrid,
SpainSite Not Available
MSD International GmbH
Lucerne 6,
SwitzerlandSite Not Available
Merck Sharp & Dohme Ltd.
Hoddesdon,
United KingdomSite Not Available
Call for Information (Investigational Site 0154)
Gilbert, Arizona 85234
United StatesSite Not Available
Call for Information (Investigational Site 0153)
Phoenix, Arizona 85013
United StatesSite Not Available
Call for Information (Investigational Site 0110)
Scottsdale, Arizona 85259
United StatesSite Not Available
Call for Information (Investigational Site 0146)
Sun City, Arizona 85351
United StatesSite Not Available
Call for Information (Investigational Site 0165)
Fayetteville, Arkansas 72703
United StatesSite Not Available
Call for Information (Investigational Site 2500)
Encino, California 91316
United StatesSite Not Available
Call for Information (Investigational Site 0163)
Fullerton, California 92835
United StatesSite Not Available
Call for Information (Investigational Site 0141)
La Jolla, California 92037
United StatesSite Not Available
Call for Information (Investigational Site 0137)
Long Beach, California 90806
United StatesSite Not Available
Call for Information (Investigational Site 0123)
Los Angeles, California 90095
United StatesSite Not Available
Call for Information (Investigational Site 0129)
Sacramento, California 95816
United StatesSite Not Available
Call for Information (Investigational Site 0150)
Sherman Oaks, California 91403
United StatesSite Not Available
Call for Information (Investigational Site 2503)
Simi Valley, California 93065
United StatesSite Not Available
Call for Information (Investigational Site 0128)
Stanford, California 94305
United StatesSite Not Available
Call for Information (Investigational Site 0114)
Valley Village, California 91607
United StatesSite Not Available
Call for Information (Investigational Site 0162)
New Haven, Connecticut 06510
United StatesSite Not Available
Call for Information (Investigational Site 0161)
Washington, District of Columbia 20057
United StatesSite Not Available
Call for Information (Investigational Site 2509)
Delray Beach, Florida 33445
United StatesSite Not Available
Call for Information (Investigational Site 0149)
Fort Myers, Florida 33912
United StatesSite Not Available
Call for Information (Investigational Site 0118)
Hialeah, Florida 33016
United StatesSite Not Available
Call for Information (Investigational Site 0151)
Hollywood, Florida 33201
United StatesSite Not Available
Call for Information (Investigational Site 0100)
Miami, Florida 33137
United StatesSite Not Available
Call for Information (Investigational Site 0113)
Miami Beach, Florida 33140
United StatesSite Not Available
Call for Information (Investigational Site 2501)
Naples, Florida 34102
United StatesSite Not Available
Call for Information (Investigational Site 0145)
Ocala, Florida 34471
United StatesSite Not Available
Call for Information (Investigational Site 2535)
Orlando, Florida 32806
United StatesSite Not Available
Call for Information (Investigational Site 0119)
Ormond Beach, Florida 32174
United StatesSite Not Available
Call for Information (Investigational Site 0160)
Palm Beach Gardens, Florida 33410
United StatesSite Not Available
Call for Information (Investigational Site 0186)
Tampa, Florida 33613
United StatesSite Not Available
Call for Information (Investigational Site 0131)
Atlanta, Georgia 30329
United StatesSite Not Available
Call for Information (Investigational Site 0152)
Chicago, Illinois 60612
United StatesSite Not Available
Call for Information (Investigational Site 0117)
Elk Grove Village, Illinois 60007
United StatesSite Not Available
Call for Information (Investigational Site 0157)
Topeka, Kansas 66606
United StatesSite Not Available
Call for Information (Investigational Site 0127)
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Call for Information (Investigational Site 0126)
Baltimore, Maryland 21208
United StatesSite Not Available
Call for Information (Investigational Site 0196)
Boston, Massachusetts 02115
United StatesSite Not Available
Call for Information (Investigational Site 0124)
Ann Arbor, Michigan 48105-2945
United StatesSite Not Available
Call for Information (Investigational Site 2502)
Saint Paul, Minnesota 55130
United StatesSite Not Available
Call for Information (Investigational Site 0158)
Mt. Arlington, New Jersey 07856
United StatesSite Not Available
Call for Information (Investigational Site 2506)
Princeton, New Jersey 08540
United StatesSite Not Available
Call for Information (Investigational Site 0138)
Toms River, New Jersey 08755
United StatesSite Not Available
Call for Information (Investigational Site 2514)
West Long Branch, New Jersey 07764
United StatesSite Not Available
Call for Information (Investigational Site 0120)
Manhasset, New York 11030
United StatesSite Not Available
Call for Information (Investigational Site 0178)
New York, New York 10032
United StatesSite Not Available
Call for Information (Investigational Site 0166)
Orangeburg, New York 10962
United StatesSite Not Available
Call for Information (Investigational Site 0140)
Rochester, New York 14620
United StatesSite Not Available
Call for Information (Investigational Site 0111)
Staten Island, New York 10312
United StatesSite Not Available
Call for Information (Investigational Site 0108)
Charlotte, North Carolina 28270
United StatesSite Not Available
Call for Information (Investigational Site 2704)
Durham, North Carolina 27705
United StatesSite Not Available
Call for Information (Investigational Site 0112)
Canton, Ohio 44718
United StatesSite Not Available
Call for Information (Investigational Site 0189)
Cincinnati, Ohio 45219
United StatesSite Not Available
Call for Information (Investigational Site 0174)
Columbus, Ohio 43210
United StatesSite Not Available
Call for Information (Investigational Site 0121)
Shaker Heights, Ohio 44122
United StatesSite Not Available
Call for Information (Investigational Site 0116)
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Call for Information (Investigational Site 0143)
Tulsa, Oklahoma 74104
United StatesSite Not Available
Call for Information (Investigational Site 2538)
Portland, Oregon 97225
United StatesSite Not Available
Call for Information (Investigational Site 0164)
Abington, Pennsylvania 19001
United StatesSite Not Available
Call for Information (Investigational Site 0195)
Allentown, Pennsylvania 18104
United StatesSite Not Available
Call for Information (Investigational Site 0199)
Norristown, Pennsylvania 19403
United StatesSite Not Available
Call for Information (Investigational Site 0101)
Philadelphia, Pennsylvania 19109
United StatesSite Not Available
Call for Information (Investigational Site 0169)
Plains, Pennsylvania 18705
United StatesSite Not Available
Call for Information (Investigational Site 0180)
Reading, Pennsylvania 19604
United StatesSite Not Available
Call for Information (Investigational Site 0164)
Willow Grove, Pennsylvania 19090
United StatesSite Not Available
Call for Information (Investigational Site 0193)
Providence, Rhode Island 02903
United StatesSite Not Available
Call for Information (Investigational Site 0133)
Charleston, South Carolina 29401
United StatesSite Not Available
Call for Information (Investigational Site 0134)
Kingsport, Tennessee 37660
United StatesSite Not Available
Call for Information (Investigational Site 0130)
Nashville, Tennessee 37203
United StatesSite Not Available
Call for Information (Investigational Site 2512)
Dallas, Texas 75231
United StatesSite Not Available
Call for Information (Investigational Site 0198)
Charlottesville, Virginia 22903
United StatesSite Not Available
Call for Information (Investigational Site 0102)
Madison, Wisconsin 53792
United StatesSite Not Available
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