Mild Alzheimer DiseasePhase 2/3PM012-2bNCT05811000
A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease
A Phase 2/3 study testing PM012 and Donepezil in people with Mild Alzheimer Disease, run by Mediforum Ltd., Co. at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Alzheimer Disease
- What is being tested?
- PM012 and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Nov 2020to 13 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Mediforum
Seoul, Seongdon-gu, 04784
Dai Won Yoo, +82.10.9412.9189, stiger9189@gmediforum.com
About this study
Official title: 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
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
Read the detailed description
This study is to establish an effective therapeutic dose in Korean patients with a mild degree of Alzheimer's disease, by comparing the safety and efficacy of the investigational product PM012 tablet administered to the 2,600 mg /day group, 3,900 mg /day group, and 5,200 mg /day group, with the active drug Aricept 5 mg (donepezil hydrochloride) from Daewoong Pharmaceuticals administered to the active control group, for 12 weeks.
- Conditions
- Mild Alzheimer Disease
- Being tested
- PM012, PM012 Placebo, Donepezil, Donepezil placebo
- Keywords
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Disease, Nervous System Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM012Drug
PM012 650 mg tablet drug
PM012 PlaceboDrug
PM012 tablet placebo
DonepezilDrug
Aricept 5 mg (donepezil hydrochloride) drug
Donepezil placeboDrug
Aricept 5 mg (donepezil hydrochloride) placebo
| Study group | Role | What they receive |
|---|---|---|
| Aricept 5 mg | Active comparator | Aricept 5 mg + Placebo of PM012 eight tablets, daily during 12 weeks (oral) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: PM012; Drug: Donepezil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 12 weeks post-dose
Secondary outcomes (6)
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 8 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.
Measured: At 8 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 8 weeks post-dose.
- The total score ranges from 0 to 53, and the lower the score, the more need to help with daily living.
Measured: At 8 weeks post-dose
CDR (Clinical Dementia Rating)
- To compare the efficacy of dose groups and active comparator group based on overall function assessed through CDR at 8 weeks and 12 weeks post-dose.
- Scores are on a scale of 0 - 5, with 0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia, 4 = profound dementia, and 5 = terminal dementia.
Measured: At 8 weeks and 12 weeks post-dose
MMSE (Mini Mental State Examination)
- To compare the efficacy of dose groups and active comparator group based on cognitive functions assessed through MMSE at 8 weeks and 12 weeks post-dose.
- The total score ranges from 0 to 30 and the lower the score, the more the cognitive problems.
Measured: At 8 weeks and 12 weeks post-dose
NPI (Neuropsychiatric Inventory)
- To compare the efficacy of dose groups and active comparator group based on behavioral change assessed through NPI at 8 weeks and 12 weeks post-dose.
- The total score ranges from 0 to 144 and the higher the score, the more neuropsychiatric symptoms.
Measured: At 8 weeks and 12 weeks post-dose
Number of participants with adverse events, with abnormal physical exam findings and abnormal laboratory tests results.
- To compare the safety of dose groups and active comparator group based on adverse events and clinical laboratory tests at 12 weeks post-dose.
Measured: At 12 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start27 Nov 2020
- Primary completion24 Feb 2021
- Study completion13 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mediforum Ltd., Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LSK Global Pharma Services Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811000
- Sponsor's protocol ID
- MFDS-31834
- Acronym
- PM012-2b
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05811000
- Acronym / sponsor ID
- PM012-2b / MFDS-31834
- Conditions
- Mild Alzheimer Disease
- Keywords
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Disease, Nervous System Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Mediforum Ltd., Co.Industry (pharma, biotech, devices)
- Collaborators
- LSK Global Pharma Services Co. Ltd.
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 13 Aug 2024 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is to establish an effective therapeutic dose in Korean patients with a mild degree of Alzheimer's disease, by comparing the safety and efficacy of the investigational product PM012 tablet administered to the 2,600 mg /day group, 3,900 mg /day group, and 5,200 mg /day group, with the active drug Aricept 5 mg (donepezil hydrochloride) from Daewoong Pharmaceuticals administered to the active control group, for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aricept 5 mg | Active comparator | Drug: PM012 Placebo, Drug: DonepezilAricept 5 mg + Placebo of PM012 eight tablets, daily during 12 weeks (oral) |
| PM012 2,600 mg | Experimental | Drug: PM012, Drug: PM012 Placebo, Drug: Donepezil placeboPM012 2,600 mg + Placebo of PM012 four tablets +Placebo of Aricept one tablet, daily during 12 weeks (oral) |
| PM012 3,900 mg | Experimental | Drug: PM012, Drug: PM012 Placebo, Drug: Donepezil placeboPM012 3,900 mg + Placebo of PM012 two tablets +Placebo of Aricept one tablet, daily during 12 weeks (oral) |
| PM012 5,200 mg | Experimental | Drug: PM012, Drug: Donepezil placeboPM012 5,200 mg + Placebo of Aricept one tablet, daily during 12 weeks (oral) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM012PM012 650 mg tablet drug | Drug | PM012 2,600 mg, PM012 3,900 mg, PM012 5,200 mg |
| PM012 PlaceboPM012 tablet placebo | Drug | Aricept 5 mg, PM012 2,600 mg, PM012 3,900 mg |
| DonepezilAricept 5 mg (donepezil hydrochloride) drug | Drug | Aricept 5 mg |
| Donepezil placeboAricept 5 mg (donepezil hydrochloride) placebo | Drug | PM012 2,600 mg, PM012 3,900 mg, PM012 5,200 mg |
Primary outcome
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Time frame: At 12 weeks post-dose
* 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.
ADCS-MCI-ADLI (Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment- Activities of Daily Living Inventory)
Time frame: At 12 weeks post-dose
* 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.
6 secondary outcomes
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Time frame: At 8 weeks post-dose
ADCS-MCI-ADLI (Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment-Activities of Daily Living Inventory)
Time frame: At 8 weeks post-dose
CDR (Clinical Dementia Rating)
Time frame: At 8 weeks and 12 weeks post-dose
MMSE (Mini Mental State Examination)
Time frame: At 8 weeks and 12 weeks post-dose
NPI (Neuropsychiatric Inventory)
Time frame: At 8 weeks and 12 weeks post-dose
Number of participants with adverse events, with abnormal physical exam findings and abnormal laboratory tests results.
Time frame: At 12 weeks post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Safety and efficacy assessment of standardized herbal formula PM012Link provided by the sponsor.
- Standardized Herbal Formula PM012 Decreases Cognitive Impairment and Promotes Neurogenesis in the 3xTg AD Mouse Model of Alzheimer's DiseaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PM012 and Donepezil in people with Mild Alzheimer Disease, run by Mediforum Ltd., Co. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dai Won Yoo (+82.10.9412.9189, stiger9189@gmediforum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) (time frame: At 12 weeks post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.