An Efficacy and Safety Trial of MK-8931 in Mild to Moderate AD (EPOCH)
- Conditions
- mild to moderate Alzheimer's DiseaseMedDRA version: 15.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-003151-20-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2211
Each subject must be ? 55 to ? 85 years of age.
Each subject must meet the criteria for a 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.
Each subject must have a Mini Mental State Examination (MMSE) score ? 15 and ? 26 at Screening.
Each subject must have a clear history of cognitive and functional decline over at least 1 year that is either a) documented in medical records or b) documented by history from an informant who knows the subject well.
Each subject must have a Magnetic Resonance Imaging (MRI) scan at the Screening Visit that is consistent with a diagnosis of AD.
Each subject must be able to read at a 6th grade level or equivalent, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.
If a subject is receiving an acetylcholinesterase inhibitor, memantine and/or herbal medications for AD, the dose must have been stable for at least 3 months before Screening, and the subject must be willing to remain on the same dose for the duration of the trial. (The treatment and dose at Screening must not be changed during the trial unless medically necessary. Additional treatments [including herbal medications] for AD that are not specified in the protocol must not be initiated during the trial.)
Each subject must have a trial partner who is reliable and competent. The trial partner must have a close relationship with the subject, have face to face contact at least 3 days/wk for a minimum of 6 waking hours/wk, be willing to accompany the subject to all trial visits, and be willing to monitor compliance of the administration of the trial medication. The trial partner should understand the nature of the trial and adhere to trial requirements (eg, dose, visit schedules, and evaluations).
Each subject must have results of clinical laboratory tests (complete blood count [CBC], blood chemistries, thyroid stimulating hormone [TSH], and urinalysis) within normal limits or clinically acceptable to the investigator at Screening.
Each subject must have results of a physical examination, vital signs, and electrocardiogram (ECG) within normal limits or clinically acceptable to the investigator at Screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1940
A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial:
The subject has a Rosen modified Hachinski Ischemia Score > 4 at Screening (ie, evidence of vascular dementia).
The subject has a known history of stroke or evidence from screening MRI scan that is clinically important in the investigator's opinion.
The subject has evidence of a clinically relevant neurological disorder other than the disease being studied (ie, probable AD) at Screening, including but not limited to: vascular dementia, parkinsonism, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic cerebral damage, cognitive impairment due to other disorders, or head trauma with loss of consciousness that led to persistent cognitive deficits.
The subject has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM IV TR criteria, including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remission is not exclusionary.
The subject has evidence of a current episode of major depression based on investigator's judgment. A score on the 15-item Geriatric Depression Scale of 5 or more requires an assessment by an appropriate health care professional to evaluate for the presence of major depression. Subjects with a score of 5 or more who are not diagnosed with major depression following such an assessment may be included in the trial.
The subject?s MRI scan obtained at Screening shows evidence of a neurological disorder other than probable AD or > 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as possible or definite), a single area of superficial siderosis, evidence of a prior macrohemorrhage, > 3 lacunar infarcts, any cortical infarct over 5 mm, or any other clinically significant finding (eg, brain tumor).
The subject has exudative (wet) age-related macular degeneration, active proliferative diabetic retinopathy, myopia or hyperopia > 8 diopters, clinically significant macula edema with diabetic retinopathy or advanced cataract to the degree that does not allow spectral-domain optical coherence tomography (SD-OCT) measurement, or other significant retinal diseases causing such significant distortion that baseline measurements would be too greatly abnormal to allow reasonable detection of possible change.
The subject has a history of hepatitis or liver disease that, in the opinion of the investigator, has been active within the 6 months prior to Screening.
The subject has a recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of the Screening Visit (such as, but not limited to, diabetes, hypertension, thyroid or endocrine disease, congestive heart failure, angina, cardiac or gastrointestinal disease, dialysis, or abnormal renal function with estimated creatinine clearance < 50 mL/min) other than the condition being studied such that, in the judgment of the investigator, participation in the trial would pose a significant medical risk to the subject. Controlled co-morbid conditions (including diabetes, hypertension, heart disease, etc) are not exclusionary, if stable within 3 months of the Screening Visit. All concomitant medications, supplements, or other substances must
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method