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MRI, FDG-PET

Phase 1

Alzheimer's Disease | Unknown | Neurology |Merck & Company, Inc.|Last Updated: Aug 11, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00757939A Study to Assess Regional Cerebral Blood Flow as an Alzheimer's Disease Biomarker Compared to Positron Emission Tomography in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects (Study MK-0000-068)(COMPLETED)PHASE1 COMPLETED 40Sep 1, 2008Oct 1, 2010Aug 11, 2015 -
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Study Endpoints
Primary Endpoints
Regional cerebral blood flow, as measured by dASL.
1 week, 6 and 12 months

Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants.

Secondary Endpoints
Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET)
12 months
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response
1 week, 6 and 12 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
AD ParticipantsEXPERIMENTALParticipants with a diagnosis of mild-to-moderate AD
Cognitively Normal Elderly ParticipantsEXPERIMENTALElderly participants with no cognitive impairment
Interventions
NameTypeDescription
MRIOTHERDuring the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.
FDG-PETOTHER2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable
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Eligibility Criteria
Age Range55 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation. The participant: * Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal; * Has been on ...

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