An Efficacy and Safety Trial of MK-8931 in Mild to Moderate Alzheimer's Disease (AD)

An Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer’s Disease

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000869875

Acronym

EPOCH

Enrollment

2211

Registered

2012-08-16

Start date

2012-12-10

Completion date

2017-04-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

55 Years to 85 Years

Healthy volunteers

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

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.

Outcome results