Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01120002
Eligibility Criteria:
Inclusion Criteria:
* Japanese patients who are diagnosed as probable Alzheimer' Disease according to NINCDS-ADRDA criteria
* Diagnosed by brain diagnostic imaging (CT, MRI) within six months before the consent and no occurrence of the event after that to suggest cerebral vascular disease
* Mild to Moderate Alzheimer's Disease of MMSE from 10 to 26
* Age from 55 to 80
* Treated for a minimum of 12 weeks with a stable dose of donepezil and willing to continue the same during the trial period
* For women Menopause ≥ 2 years
* For men contraceptive measures are required during the study and after 6 months
* In principle patients should be living at their home in the presence of a caregiver who is defined as a healthy person in contact with the patient for more than 10 hours a week, could provide required information of the behavior and activities of daily living, accompany all the clinical examination, and supervise the handling and administration of the drug throughout the study period.
* Patients who could take pills as a whole
* Patient, caregiver and patient surrogate are able and willing to comply with study visits and procedures per protocol, understand, sign, and date the written voluntary informed consent form
Exclusion Criteria:
* Any cause of dementia not due to Alzheimer's disease
* Past history of other central nervous condition or psychiatric disease
* Symptom of depression and drug addiction
* Impairment in the physical function by other factor than the Alzheimer's Disease
* Patients who are expected to move in to care facilities during the study period
* triglyceride \> 400 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT01120002
Study Brief:
Protocol Section:
NCT01120002