Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimer's Disease (MK-7622-012)



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 85
Updated:2/27/2016
Start Date:October 2013
End Date:April 2020
Contact:Toll Free Number
Phone:1-888-577-8839

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A Seamless Phase IIa/IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of MK-7622 as an Adjunctive Therapy for Symptomatic Treatment in Subjects With Alzheimer's Disease

The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622
compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for
the symptomatic treatment of participants with mild to moderate Alzheimer's Disease (AD).
The trial consists of two stages: Stage 1 and Stage 2. Participants in Stage 1 will be
randomized to receive either placebo or MK-7622 45 mg once daily. In Stage 2, participants
will be randomized to receive either placebo, or MK-7622 5, 15 or 45 mg once daily.
Participants will be enrolled in only one stage. Interim analyses will be performed in both
Stage 1 and Stage 2 to determine whether the trial should continue. Duration of each stage
is approximately 26 weeks; all participants receive placebo at some time during the trial.
The primary study hypotheses are the following: Stage 1 - MK-7622 45 mg once daily is
superior to placebo in improving cognition in participants with mild to moderate AD as
assessed by mean change from baseline in the 11-item Alzheimer's Disease Assessment
Scale-Cognitive Subscale (ADAS-Cog11) at Week 12; Stage 2 - At least one of the top two
doses of MK-7622 (15 mg once daily, 45 mg once daily) is superior to placebo in improving
cognition in participants with mild to moderate AD as assessed by mean change from baseline
in ADAS-Cog11 at Week 12.

If double-blind treatment dose is not tolerated during first 2 weeks, participant will be
discontinued. After first 2 weeks, if dose is not tolerated regimen may be modified
according to defined algorithm, beginning with administration of reduced dose for up to 2
weeks, then rechallenge at original dose, if tolerability issues diminish or resolve at
reduced dose.

Inclusion Criteria:

- Diagnosis of probable AD based on both a) the National Institute of Neurological and
Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders
Association (NINCDS-ADRDA) criteria and b) the Diagnostic and Statistical Manual of
Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for AD

- AD is of mild to moderate severity

- Clear history of cognitive and functional decline over at least one year that is
either a) documented in medical records or b) documented by history from an informant
who knows the participant well

- On a stable and effective daily dose of AChEI (either donepezil, rivastigmine, or
galantamine), for at least two months before Screening, and willing to remain on the
same dose for the duration of the trial. Effective doses are considered to be:
donepezil, 10 mg total daily dose administered orally; rivastigmine, 9.5 or 13.3
mg/24 hours administered by transdermal patch or 6-12 mg total daily dose
administered orally; galantamine, 16-24 mg total daily dose administered orally

- Able to read at a 6th grade level or equivalent, and must have a history of academic
achievement and/or employment sufficient to exclude mental retardation

- Participant must have a reliable and competent trial partner who must have a close
relationship with the subject

Exclusion Criteria:

- History of clinically significant stroke

- Evidence of a neurological disorder other than the disease being studied (ie,
probable AD)

- History of seizures or epilepsy within the last 5 years before Screening

- Evidence of a clinically relevant or unstable psychiatric disorder, excluding major
depression 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 before
Screening

- Participant does not have a magnetic resonance imaging (MRI) scan obtained within 12
months of Screening and is unwilling or not eligible to undergo an MRI scan at
Screening

- History of hepatitis or liver disease that has been active within the six months
prior to Screening Visit

- Recent or ongoing, uncontrolled, clinically significant medical condition within 3
months of the Screening Visit (e.g., diabetes, hypertension, thyroid or endocrine
disease, congestive heart failure, angina, cardiac or gastrointestinal disease,
dialysis, or abnormal renal function) other than the condition being studied such
that participation in the trial would pose a significant medical risk to the
participant. Controlled co-morbid conditions are not exclusionary if stable within
three months of the Screening Visit

- History or current evidence of long QT syndrome, corrected QT (QTc) interval ≥470
milliseconds (for male subjects) or ≥480 milliseconds (for female subjects), or
torsades de pointes

- History of malignancy occurring within the five years before Screening, except for
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
or localized prostate carcinoma which has been treated with potentially curative
therapy with no evidence of recurrence for ≥3 year posttherapy

- Clinically significant vitamin B12 deficiency, or increased thyroid stimulating
hormone (TSH) in the six months before Screening

- Major surgery within 3 months of Screening
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