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:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT01715350
Eligibility Criteria:
Inclusion Criteria:
* 1)Male and female patients aged ≥ 50 and ≤ 85 years
* 2)Clinically diagnosed with probable Alzheimer's disease based on DSM-IV and NINCDS-ADRDA criteria
* 3)K-MMSE score of 12\~26 at screening visit
* 4)For females: 2 years of confirmed menopause or surgical sterilization.
* 5)Able to walk (including the use of aids)
* 6)Able to perform procedures for cognitive and other tests
* 7)Residing with a life-long guardian willing to accompany the subject's on all visits, oversee his/her compliance with the procedures specified in the protocol and the study drug, and report his/her condition.
* 8)Having signed him/herself or his/her legally acceptable representative having signed the written informed consent form
Exclusion Criteria:
* 1)Possible, probable, or definite vascular dementia by NINDS-AIREN criteria
* 2)History and/or evidence (result of CT or MRI performed within the past 12 months or at screening) of other CNS disease (cerebrovascular disease, structural or developmental anomaly, epilepsy, contagious, degenerative or infectious/demyelinating CNS condition) as a cause of dementia
* 3)Delusion, delirium, epilepsy and other neurological pathology on neurological examination
* 4)Abnormal test result on vitamin B12, syphilis serology, and thyroid stimulating hormone (TSH) tests that are thought to contribute to the subject's dementia severity or be a cause of dementia
* 5)History of significant psychiatric disease such as schizophrenia or bipolar affective disorder that may interfere with the participation in this study in the opinion of the investigator, or current depression (GDS ≥ 18)
* 6)Past history of known or suspected seizures including febrile convulsion, unexplained recent unconsciousness or past history of significant head trauma with unconsciousness.
* 7)Gastrointestinal, endocrine and cardiovascular disease not controlled by diet or pharmacologic therapy
* 8)Cardiac disease such as myocardial infarction or valvular disease of heart, arrhythmia within 3 months of the study start
* 9)Diabetes mellitus not controlled by hypoglycemic agent or insulin-dependent diabetes mellitus
* 10)Past history of alcohol or other drug abuse
* 11)Having taken acetylcholinesterase inhibitor or memantine within the past 3 months
* 12)Hypertension with systolic blood pressure of \> 165 mmHg or diastolic blood pressure of \> 96 mmHg
* 13)Severe renal impairment (serum creatinine ≥ 1.7 mg/dl)
* 14)Severe hepatic impairment (ALT, AST, or bilirubin ≥ 2.0 x upper limit of normal)
* 15)Is taking or expected to take disallowed concomitant medication
* 16)History of clinically significant drug hypersensitivity
* 17)Is ineligible to participate in this study in the judgment of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01715350
Study Brief:
Protocol Section:
NCT01715350