Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000869875
Ethics application status
Approved
Date submitted
27/07/2012
Date registered
16/08/2012
Date last updated
11/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An Efficacy and Safety Trial of MK-8931 in Mild to Moderate Alzheimer's Disease (AD)
Scientific title
An Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer’s Disease
Secondary ID [1] 280918 0
EUCTR2011-003151-20
Universal Trial Number (UTN)
Trial acronym
EPOCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 286999 0
Condition category
Condition code
Neurological 287333 287333 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MK-8931 12mg tablets, orally once daily for 78 weeks
MK-8931 40mg tablets, orally once daily for 78 weeks
MK-8931 60mg tablets, orally once daily for 78 weeks
Participants will be randomised to one of these 3 treatments or a matching placebo tablet.
Intervention code [1] 285354 0
Treatment: Drugs
Comparator / control treatment
matching placebo tablets, identical to MK-8931 but without the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 287605 0
change from Baseline in ADAS-Cog score
Timepoint [1] 287605 0
78 weeks
Primary outcome [2] 287606 0
change from Baseline in ADCS-ADL score
Timepoint [2] 287606 0
78 weeks
Secondary outcome [1] 298521 0
change-from-Baseline in CDR-SB score
Timepoint [1] 298521 0
78 weeks
Secondary outcome [2] 298522 0
change-from-Baseline in total hippocampal
volume using MRI.
Timepoint [2] 298522 0
78 weeks
Secondary outcome [3] 298523 0
change-from-Baseline in Cerebral Spinal Fluid total tau concentration by laboratory analysis
Timepoint [3] 298523 0
78 weeks

Eligibility
Key inclusion criteria
Mild to Moderate Alzheimer's Disease with an MMSE score between 15 and 26. Each subject must have a reliable and competent trial partner/caregiver who has
a close relationship with the subject
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
evidence of vascular dementia or stroke. Other clinically relevant neurological disorder. Clinically relevant or unstable psychiatric disorders. History of hepatitis or liver disease within the previous 6 months. History of malignancy occurring within the previous five years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
On 14Feb2017, Merck is stopping the study following the recommendation of the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during a recent interim safety analysis, and determined that there was “virtually no chance of finding a positive clinical effect.” The eDMC noted that safety signals observed in the study “are not sufficient to warrant stopping study 017"
Date of first participant enrolment
Anticipated
11/12/2012
Actual
10/12/2012
Date of last participant enrolment
Anticipated
29/01/2016
Actual
14/04/2017
Date of last data collection
Anticipated
27/06/2017
Actual
12/07/2017
Sample size
Target
1960
Accrual to date
Final
2211
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 4468 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 4469 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 4470 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [4] 4471 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [5] 4472 0
Hollywood Private Hospital - Nedlands
Recruitment outside Australia
Country [1] 4425 0
New Zealand
State/province [1] 4425 0
Country [2] 4426 0
Argentina
State/province [2] 4426 0
Country [3] 4427 0
Austria
State/province [3] 4427 0
Country [4] 4428 0
Belgium
State/province [4] 4428 0
Country [5] 4429 0
Brazil
State/province [5] 4429 0
Country [6] 4430 0
Canada
State/province [6] 4430 0
Country [7] 4431 0
Czech Republic
State/province [7] 4431 0
Country [8] 4432 0
Denmark
State/province [8] 4432 0
Country [9] 4433 0
France
State/province [9] 4433 0
Country [10] 4434 0
Germany
State/province [10] 4434 0
Country [11] 4435 0
Hungary
State/province [11] 4435 0
Country [12] 4436 0
Italy
State/province [12] 4436 0
Country [13] 4437 0
Japan
State/province [13] 4437 0
Country [14] 4438 0
Korea, Republic Of
State/province [14] 4438 0
Country [15] 4439 0
Netherlands
State/province [15] 4439 0
Country [16] 4440 0
Portugal
State/province [16] 4440 0
Country [17] 4441 0
Spain
State/province [17] 4441 0
Country [18] 4442 0
Turkey
State/province [18] 4442 0
Country [19] 4443 0
United Kingdom
State/province [19] 4443 0
Country [20] 4444 0
United States of America
State/province [20] 4444 0
Country [21] 7241 0
Brazil
State/province [21] 7241 0
Country [22] 7242 0
Israel
State/province [22] 7242 0

Funding & Sponsors
Funding source category [1] 285702 0
Commercial sector/Industry
Name [1] 285702 0
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Country [1] 285702 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Address
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100, U.S.A.
Country
United States of America
Secondary sponsor category [1] 284530 0
None
Name [1] 284530 0
Address [1] 284530 0
Country [1] 284530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287701 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 287701 0
Level 3, Hanson Institute
North Terrace
Adelaide 5000
South Australia
Ethics committee country [1] 287701 0
Australia
Date submitted for ethics approval [1] 287701 0
20/07/2012
Approval date [1] 287701 0
23/11/2012
Ethics approval number [1] 287701 0

Summary
Brief summary
A study to test the efficacy and safety of investigational therapy MK-8931 in the treatment of mild to moderate Alzheimer's Disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34490 0
A/Prof Michael Woodward
Address 34490 0
Heidelberg Repatriation Hospital
145 Studley Road
Heidelberg VIC 3084,
Country 34490 0
Australia
Phone 34490 0
+61,3,94962987
Fax 34490 0
Email 34490 0
[email protected]
Contact person for public queries
Name 17737 0
Dr Michael F. Egan, MD
Address 17737 0
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100, U.S.A.
Country 17737 0
United States of America
Phone 17737 0
+1 (267) 305-7678
Fax 17737 0
Email 17737 0
[email protected]
Contact person for scientific queries
Name 8665 0
Dr Michael F. Egan, MD
Address 8665 0
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100, U.S.A.
Country 8665 0
United States of America
Phone 8665 0
+1 (267) 305-7678
Fax 8665 0
Email 8665 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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