Study to Explore the Optimal Dosage/Administration in Alzheimer's Disease

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators intend to perform exploratory evaluation of the treatment effectiveness and safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose with placebo control for the efficacy and safety to explore the clinically optimal dose of PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purimed Co., Ltd.; VTBIO Co. LTD
• Collaborator: ADM Korea Inc

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