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Alzheimer's DiseasePhase 2ADDNCT01715350

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

A Phase 2 study testing PM012 in people with Alzheimer's Disease, run by VTBIO Co. LTD at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
PM012
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
4 sitesSouth Korea
Study dates
May 2012to Jun 2015
Phase
Phase 2
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)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

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • National Health Insurance Corporation Ilsan Hospital

    Goyang, Ilsandong-gu, 410-719

  • Kyung Hee University Oriental Medicine Hospital

    Seoul, Dongdaemun-gu, 130-872

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, Seocho-gu, 137-701

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Paldal-gu, 442-72

Other trials in South Korea

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

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.

Read the detailed description
  1. Period of study -48 months from the date of KFDA approval of the protocol
  2. Study subjects -Patients with mild to moderate Alzheimer's disease
  3. Study objectives
  4. Primary objective
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose
  1. Secondary objectives
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 8 post-dose
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on overall functional effect assessed by CDR at Weeks 8 and 12 post-dose
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on behavioral changes assessed by NPI at Weeks 8 and 12 post-dose
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose
  • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on improvement on VAS assessed by Senile Dementia Pattern Identification Diagnosis System at Weeks 8 and 12 post-dose
  1. Study drug / Comparator -650-mg PM012 Tablet by PuriMED Co., Ltd. / Placebo
  2. Dosage/ Administration and Method of administration
  3. Placebo group
  • Morning:Placebo 2T, Evening:Placebo 2T
  1. Dose group 1
  • Morning:Placebo 1T+Study drug 1T, Evening:Placebo 1T+Study drug 1T
  1. Dose group 2
  • Morning:Study drug 2T, Evening:Study drug 2T
  1. Study drug is 650-mg PM012 tablet
  2. The drug will be taken with water within 30 minutes after breakfast and supper.
  3. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
  4. Treatment duration -12 weeks
  5. Number of subjects
  6. placebo group
  • Efficacy population:42, Drop-out(20%)included:53
  1. Dose group 1
  • Efficacy population:42, Drop-out(20%)included:53
  1. Dose group 2
  • Efficacy population:42, Drop-out(20%)included:53
  1. Total
  • Efficacy population:126, Drop-out(20%)included:159
  1. Study method
  • This study is designed to be a multicenter, randomized, double-blind, parallel placebo group and 2 dose groups, phase 2 clinical study in patients with dementia of Alzheimer's type aged ≥ 50 and ≤ 85 years.
  • Once a subject voluntarily provides the written consent to participate in the study, he/she will be randomized only if meeting the inclusion criteria and exclusion criteria through screening test. Randomized subjects will receive the study drug or the placebo for 12 weeks.
Being tested
PM012, Placebo
Keywords
Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PM012Drug

    Also called 650-mg PM012 tablet

    • The drug will be taken with water within 30 minutes after breakfast and supper.
    • 650mg/1 tablet, PO, 12weeks

  • PlaceboDrug

    Also called Placebo (for PM012)

    • The drug will be taken with water within 30 minutes after breakfast and supper.
    • 650mg/1 tablet, PO, 12weeks
Study groups in NCT01715350
Study groupRoleWhat they receive
Placebo groupPlacebo comparator• Drug : Placebo 2 tablet The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
Receives: Drug: Placebo
Dose group 1Experimental* Drug : Placebo 1 tablet + Study drug 1 tablet * Study drug(650-mg PM012 tablet) The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
Receives: Drug: PM012; Drug: Placebo
Dose group 2Experimental* Drug : Study drug 2 tablet * Study drug (650-mg PM012 tablet) The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
Receives: Drug: PM012

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADAS-cog

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose

    Measured: Week 12 post-dose

Secondary outcomes (7)

  1. ADAS-cog

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 8 post-dose

    Measured: Weeks 8 post-dose

  2. CDR

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on overall functional effect assessed by CDR at Weeks 8 and 12 post-dose

    Measured: Weeks 8 and 12 post-dose

  3. K-IADL

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose

    Measured: Weeks 8 and 12 post-dose

  4. NPI

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on behavioral changes assessed by NPI at Weeks 8 and 12 post-dose

    Measured: Weeks 8 and 12 post-dose

  5. K-MMSE

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose

    Measured: Weeks 8 and 12 post-dose

  6. VAS

    • To compare the efficacy of 2 doses of PM012 Tablet and placebo based on improvement on VAS assessed by Senile Dementia Pattern Identification Diagnosis System at Weeks 8 and 12 post-dose

    Measured: at Weeks 8 and 12 post-dose

  7. AE

    • To compare the safety based on treatment-emergent adverse events, laboratory tests (hematology/blood chemistry, urinalysis), physical examination, vital signs

    Measured: while the subject is receiving the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2014
  4. Study completionJun 2015

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715350
Sponsor's protocol ID
PM012-P2
Acronym
ADD
Status last verified
Apr 2016
First submitted
24 Oct 2012
Last updated
18 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PM012 in people with Alzheimer's Disease, run by VTBIO Co. LTD at 4 sites 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADAS-cog (time frame: Week 12 post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01715350.

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 2016.

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