A Study of the Safety, Tolerability, and Pharmacodynamics of MK-8931 in Participants With Alzheimer's Disease (MK-8931-010 AM1 [P07820 AM1])

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01496170

First received: December 6, 2011

Last updated: July 13, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 6, 2011
Last Updated Date	July 13, 2012
Start Date ^ICMJE	December 2011
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 16, 2011)	Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40) [ Time Frame: Hour 0 (predose) to 36 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01496170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 16, 2011)	Change in CSF Aß40 concentration determined by time-weighted average from 0 to 24 hours (TWA0-24) [ Time Frame: Baseline, and assessment over 24 hours post Day 7 dose ] [ Designated as safety issue: No ] Change in CSF soluble amyloid precursor protein ß (sAPPß ) concentration determined by TWA0-24 [ Time Frame: Baseline, and assessment over 24 hours post Day 7 dose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of the Safety, Tolerability, and Pharmacodynamics of MK-8931 in Participants With Alzheimer's Disease (MK-8931-010 AM1 [P07820 AM1])
Official Title ^ICMJE	A Study to Assess the Safety, Tolerability, and Pharmacodynamics of MK-8931/SCH 900931 in Patients With Alzheimer's Disease [Phase 1b; Protocol No. 010-00 (Also Known as P07820)]
Brief Summary	This study will assess the safety and pharmacodynamics of three different doses of MK-8931, a ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: MK-8931 MK-8931, capsules, at a dose of 12 or 40 mg, orally, once per day for 7 days Other Name: SCH 900931 Drug: Placebo Placebo capsules, orally, once per day for 7 days
Study Arm (s)	Experimental: Treatment A: MK-8931 12 mg Participants receiving 12 mg MK-8931 for 7 days Intervention: Drug: MK-8931 Experimental: Treatment B: MK-8931 40 mg Participants receiving MK-8931 40 mg for 7 days Intervention: Drug: MK-8931 Placebo Comparator: Treatment C: Placebo matching MK-8931 12 mg or 40 mg Participants receiving placebo matching MK-8931 12 mg or 40 mg for 7 days Intervention: Drug: Placebo Experimental: Treatment D: MK-8931 60 mg Participant receiving MK-8931 60 mg for 7 days Intervention: Drug: MK-8931 Placebo Comparator: Treatment E: Placebo matching MK-8931 60 mg Participants receiving placebo matching MK-8931 60 mg for 7 days Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	June 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: Body Mass Index (BMI) between 18 and 35 Mild to moderate Alzheimer's Disease (AD) Clear history of cognitive and functional decline over at least one year that is either documented in medical records, or documented by history from an informant who knows the subject well Magnetic Resonance Image (MRI) scan consistent with a diagnosis of AD Ability to read at a 6th grade level and history of academic achievement and/or employment sufficient to exclude mental retardation If applicable, on a stable dose of an acetylcholinesterase inhibitor and/or memantine for at least the last 3 months before Screening, and willing to remain on the same dose for the duration of the trial Reliable trial partner/caregiver Willing to provide a blood sample for Apolipoprotein E (APOE) genotyping In general good health (other than AD) Participant capable of conceiving and/or participant with partner capable of conceiving willing to use a medically acceptable form of contraception during the trial and for 3 months after stopping the medication Exclusion criteria: History (within 2 years of the prestudy visit) or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition Clinically significant abnormalities in serum vitamin B12, folate, thyroid stimulating hormone (TSH) or thyroxin 4 (T4). Vitamin B12 or thyroid replacement therapy must with stable dose for at least 2 months prior to screening visit One or more pre-existing risk factors for Torsades de Pointes: New York Heart Association (NYHA) Functional Classification II through IV heart failure; Familial Long QT Syndrome; or Uncorrected hypokalemia Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug History of spinal cord compression or any other current abnormalities in the lumbar region (skin infection, developmental abnormalities in lower spine, etc.) History of any infectious disease within 4 weeks prior to drug administration Human immunodeficiency virus (HIV) positive History of hepatitis or liver disease within 6 months of screening History of psychiatric or personality disorders Evidence of suicidality or is at risk for self-harm or harm to others History of seizures or epilepsy or anticonvulsant use within the last 5 years before Screening History of alcohol or drug abuse in the past 2 years Donation of blood in the past 60 days Previously received the study drug Currently participating in another clinical study or have participated in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline Member of the study staff or family members of the study staff Demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) History of malignancy occurring within the 5 years immediately before Screening, except for a subject who has been adequately treated for basal cell or squamous cell skin cancer, in situ cervical cancer, localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of recurrence for ≥1 year post-therapy, and deemed at low risk for recurrence by her/his treating physician
Gender	Both
Ages	50 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01496170
Other Study ID Numbers ^ICMJE	P07820, MK-8931-010
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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