Phase
Condition
Memory Loss
Mental Disability
Alzheimer's Disease
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.