PM012-2b

UnknownPhase 2 / PHASE3

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

A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease: Double-Blind, Randomized Between Placebo Control Group and Dose Groups, Parallel-Design, Multicenter Study

Lead sponsor

Mediforum Ltd., Co.

Assets

Donepezil / PM012

Listed sites

Recruiting sites

Enrollment

312

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global 0.5•MMSE 20

Primary endpoints

•ADAS-Cog•ADCS-MCI-ADLI

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDMFDS-31834

NCT IDNCT05811000

Timeline

Milestones

Study start2020-11-27actual

Primary completion2021-02-24actual

Study first posted2023-04-13actual

Last update posted2023-04-18actual

Study completion2024-08-13estimated

Assets

Drug assets

Donepezil PM012

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1) Male and female patients aged ≥ 50 and ≤ 85 years.

•2) Patients clinically diagnosed as probable Alzheimer's disease based on DSM-IV and NINCDS-ADRDA criteria.

•3) Patients between MMSE score of 20~26 at 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

•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 as needed).

•24) Patients with a history of clinically significant drug hypersensitivity reaction.

•25) Patients who have been administered investigational products from another clinical trial within 3 months prior to participation in this trial.

•26) Patients who are deemed unfit to participate in this trial by the investigator.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

4 endpoints

Primary/protocol endpoint

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

Time frame:At 12 weeks post-dose

ADAS-Cog

descriptive

Secondary/protocol endpoint

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

Time frame:At 8 weeks post-dose

ADAS-Cog

descriptive

Secondary/protocol endpoint

CDR (Clinical Dementia Rating)

Time frame:At 8 weeks and 12 weeks post-dose

descriptive

Secondary/protocol endpoint

MMSE (Mini Mental State Examination)

Time frame:At 8 weeks and 12 weeks post-dose

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

2 endpoints

Primary/protocol endpoint

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

Time frame:At 12 weeks post-dose

descriptive

Secondary/protocol endpoint

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

Time frame:At 8 weeks post-dose

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

NPI (Neuropsychiatric Inventory)

Time frame:At 8 weeks and 12 weeks post-dose

Neuropsychiatric Inventory (NPI)

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of participants with adverse events, with abnormal physical exam findings and abnormal laboratory tests results.

Time frame:At 12 weeks post-dose

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.