A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease

NCT05811000 | Unknown Phase 2

• 1 other identifier: MFDS-31834
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of PM012 tablets for Alzheimer's disease, dose-finding study will be performed on phase 2b, and the established dose will be used for the non-inferiority phase 3 trial to evaluate the investigational product's safety and efficacy: Double blind, randomized, active drug comparative, multi-center, parallel-group clinical trial

Conditions

Mild Alzheimer Disease

Keywords

Alzheimer's Disease; Dementia; Brain Diseases; Central Nervous System Disease; Nervous System Disease

Outcome Measures

Primary Outcomes (2)

• ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)

  * To compare the efficacy of dose groups and active comparator group based on cognitive functions assessed through ADAS-cog at 12 weeks post-dose. * The total score ranges from 0 (no function) to 70 (maximal function), and the higher the score, the greater the cognitive impairment.

  At 12 weeks post-dose

• ADCS-MCI-ADLI (Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment- Activities of Daily Living Inventory)

  * To compare the efficacy of dose groups and active comparator group based on activities of daily living assessed through ADCS-MCI-ADLI at 12 weeks post-dose * The total score ranges from 0 to 53, and the lower the score, the more the participant needs help with daily living.

  At 12 weeks post-dose

Secondary Outcomes (6)

• ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)

  At 8 weeks post-dose

• ADCS-MCI-ADLI (Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment-Activities of Daily Living Inventory)

  At 8 weeks post-dose

• CDR (Clinical Dementia Rating)

  At 8 weeks and 12 weeks post-dose

• MMSE (Mini Mental State Examination)

  At 8 weeks and 12 weeks post-dose

• NPI (Neuropsychiatric Inventory)

  At 8 weeks and 12 weeks post-dose

Study Arms (4)

Aricept 5 mg

ACTIVE COMPARATOR

Aricept 5 mg + Placebo of PM012 eight tablets, daily during 12 weeks (oral)

Drug: PM012 Placebo; Drug: Donepezil

PM012 2,600 mg

EXPERIMENTAL

PM012 2,600 mg + Placebo of PM012 four tablets +Placebo of Aricept one tablet, daily during 12 weeks (oral)

Drug: PM012; Drug: PM012 Placebo; Drug: Donepezil placebo

PM012 3,900 mg

EXPERIMENTAL

PM012 3,900 mg + Placebo of PM012 two tablets +Placebo of Aricept one tablet, daily during 12 weeks (oral)

Drug: PM012; Drug: PM012 Placebo; Drug: Donepezil placebo

PM012 5,200 mg

EXPERIMENTAL

PM012 5,200 mg + Placebo of Aricept one tablet, daily during 12 weeks (oral)

Drug: PM012; Drug: Donepezil placebo

Interventions

PM012 DRUG

PM012 650 mg tablet drug

PM012 2,600 mg; PM012 3,900 mg; PM012 5,200 mg

PM012 Placebo DRUG

PM012 tablet placebo

Aricept 5 mg; PM012 2,600 mg; PM012 3,900 mg

Donepezil DRUG

Aricept 5 mg (donepezil hydrochloride) drug

Aricept 5 mg

Donepezil placebo DRUG

Aricept 5 mg (donepezil hydrochloride) placebo

PM012 2,600 mg; PM012 3,900 mg; PM012 5,200 mg

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Male and female patients aged ≥ 50 and ≤ 85 years.
• \) Patients clinically diagnosed as probable Alzheimer's disease based on DSM-IV and NINCDS-ADRDA criteria.
• \) Patients between MMSE score of 20\~26 at screening visit.
• \) Patients with Global CDR score of 0.5 or 1 at the screening visit.
• \) Patients administered with donepezil 5㎎ stably for over 3 months or who have never been administered donepezil.
• \) Patients who can perform cognitive or other necessary tests.
• \) 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).
• \) 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.
• \) Patients who have signed the informed consent on his/her own will

You may not qualify if:

• \) Patients with hypersensitivity to the investigational product or components contained in the investigational product.
• \) Patients with hypersensitivity to piperidine derivatives.
• \) Patients with possible, probable or definite vascular dementia according to the NINDS-AIREN criteria.
• \) 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.
• \) Patients who are illiterate.
• \) Patients with severe hearing or visual disabilities so that efficacy assessment is impossible.
• \) 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.
• \) 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).
• \) Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• \) 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.
• \) Patients with gastrointestinal, endocrinological, or cardiovascular disorders that is not controlled by diet or drugs.
• \) Patients with cardiac diseases such as myocardial infarction, valvular heart disease, or arrhythmia within 3 months prior to screening.
• \) Patients with asthma or obstructive pulmonary diseases that is not controlled by drugs.
• \) Patients with extrapyramidal disorders (Parkinson's disease, Parkinsonism, etc).
• \) Patients with dementia due to Creutzfeldt-Jakob disease, Pick's disease, or Huntington's disease.

Sponsors & Collaborators

• Mediforum Ltd., Co.: lead
• LSK Global Pharma Services Co. Ltd.: collaborator

Study Sites (1)

Mediforum

Seoul, Seongdon-gu, 04784, South Korea

RECRUITING

Related Links

• Safety and efficacy assessment of standardized herbal formula PM012
• Standardized Herbal Formula PM012 Decreases Cognitive Impairment and Promotes Neurogenesis in the 3xTg AD Mouse Model of Alzheimer's Disease

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Dai Won Yoo

CONTACT

+82.10.9412.9189; stiger9189@gmediforum.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 13, 2023
• Study Start: November 27, 2020
• Primary Completion: February 24, 2021
• Study Completion: August 13, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

KR (1)