None listed
Conditions
Interventions
Drug : To establish an effective therapeutic dose in Korean patients with a mild to intermediate degree of Alzheimer’s disease, by comparing the safety and efficacy of the investigational product PM01
Sponsors
LSK Global Pharma Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female patients between 50 and 85 years of age 2) Patients clinically diagnosed as probable Alzheimer’s disease based on the DSM-IV and NINCDS-ADRDA criteria 3) Patients between MMSE scores of 2018-26 at the screening visit 4) Patients with Global CDR score of 0.5 or 1 at the screening visit 5) Patients administered with donepezil 5? stably for over 3 months or who have never been administered donepezil 6) Patients who can perform cognitive or other necessary tests 7) Patients who have a caretaker who can accompany the patient for all clinical visits and for the primary efficacy evaluation (a caretaker is a family member or someone trustworthy who provides care for daily activities, spending more than 8 hours per week with patients.) 8) Patients who have consented to participate in medically acceptable contraception* * Effective contraception methods: Infertility surgery of the patient or his/her spouse (vasectomy, tubal ligation), placement of an intrauterine contraceptive device, double barrier method (concomitant use of spermicides and condoms, and contraceptive diaphragms, vaginal sponges, or cervical caps). Oral contraceptives and intermittent celibacy (absolute celibacy is allowed) are not acknowledged as effective contraceptive methods. 9) Patients who have signed the informed consent on his/her own will
Exclusion criteria
Exclusion criteria: 1) Patients with hypersensitivity to the investigational product or components contained in the investigational product 2) Patients with hypersensitivity to piperidine derivatives 3) Patients with possible, probable or definite vascular dementia according to the NINDS-AIREN criteria 4) History (cerebrovascular disease, structural or developmental malformations, epilepsy, contagious, degenerative, or infectious/demyelinating CNS status) and/or evidence (CT or MRI results performed at screening or within 12 months) of other CNS diseases as the major cause of dementia 5) Patients who are illiterate 6) Patients with severe hearing or visual disabilities so that efficacy assessment is impossible 7) Abnormal test results for vitamin B12, serologic testing for syphilis, or thyroid stimulating hormone (TSH) that may have contributed to or may be the cause of patient’s dementia 8) Patients with a history of significant psychiatric disease such as schizophrenia or bipolar disorder that may interfere with participation in the trial as viewed by the investigator, or patients with current major depression disorder (Short Form GDS = 7) (However, patients who depressed due to Alzheimer's disease can participate in this trial by the investigator) 9) Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 10) Patients with a history of known or suspected seizure including febrile seizure, or recent history of loss of consciousness or a history of significant head trauma with loss of consciousness 11) Patients with gastrointestinal, endocrinological, or cardiovascular disorders that is not controlled by diet or drugs 12) Patients with cardiac diseases such as myocardial infarction, valvular heart disease, or arrhythmia within 3 months prior to screening 13) Patients with asthma or obstructive pulmonary diseases that is not controlled by drugs 14) Patients with extrapyramidal disorders (Parkinson’s disease, Parkinsonism, etc.) 15) Patients with dementia due to Creutzfeldt-Jakob disease, Pick’s disease, or Huntington’s disease 16) Patients with uncontrolled diabetes (HbA1c > 8.0%) or insulin dependent diabetes 17) Patients with a history of alcohol or other substance abuse 18) Patients with hypertension with systolic pressure over 165mmHg or diastolic pressure over 96mmHg 19) Patients with severe renal dysfunction (Serum creatinine over 2.0?/dl) 20) Patients with severe liver dysfunction (ALT, AST, total bilirubin more than 2.5-fold the upper normal limit) 21) Patient who has been administered drugs that Dementia drugs(Donepezil, Galantamine, Memantine, Rivastigmine tartrate) within 3 months prior to screening (However, patients who have been administered donepezil 5mg stably for over 3 months are excluded) 22) Patient who has required to take restricted drugs other than investigational products during the clinical trial period 23) patient who has unabled to take concomitant drugs during the clinical trial period under the following conditions : - It was taken without dose change 2 months before randomization, and was taken without dose change during the clinical trial period (except for drugs allowed to be taken if pro re nata; PRN) 24) Patients with a history of clinically significant drug hypersensitivity reaction 25) Patients who have bee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cognitive functions as assessed through ADAS-cog;activities of daily living inventory as assessed through ADCS-MCI-ADLI | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ADAS-cog scores;Change in ADCS-MCI-ADLI scores ;Change in CDR scores ;Change in MMSE scores ;Change in NPI scores | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Uk Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed