Alzheimer DiseasePIT-ROADNCT00548145
The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease
A study testing Pitavastatin and cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) in people with Alzheimer Disease and Hypercholesterolemia, run by Osaka University at 1 site in Japan.
Trial summary
Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Alzheimer Disease, Hypercholesterolemia
- What is being tested?
- Pitavastatin and cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR "1" or "2")
- Patients with hypercholesterolemia
- Patients who have taken donepezil more than 3 months stably
- Both patients and care-givers must be more than 20 years old
Who cannot join
- Women with pregnancy or breast-feeding
- Malignant tumor
- Cerebrovascular disorder or myocardial infarction prior to 12 weeks
- Heart failure [New York Heart Association (NYHA) class III or IV]
- Hepatic or renal dysfunction
- Severe hypertension
Show all 9Show fewer
- Hypothyroidism, hereditary muscular disease, history of drug-induced myopathy
- Current involvement in another investigational drug study
- Alcoholism, drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.
Read the detailed description
The PIT-ROAD study will include 50 patients who have taken donepezil more than 3 months stably. This study will see how the use of a particular statin medication, pitavastatin, affects ADAS-Jcog score etc. and cholesterol.
Participants will be given a full information of the study and written informed consent should be obtained before entering the study. Participants will take part in 5 visits over the course of 12 months. If participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. Participants will undergo 8 tests (ADAS-Jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.
- Conditions
- Alzheimer Disease, Hypercholesterolemia
- Being tested
- Pitavastatin, cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
- Keywords
- Pitavastatin, Statins, Donepezil, Alzheimer's Disease, Hypercholesterolemia, ADAS-Jcog, Alzheimer Disease (MMSE 15-23 and CDR1 or 2)
- Medical subject headings
- Alzheimer Disease, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
2 mg by orally/day Duration: 12 months
cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)Drug
duration: 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pitavastatin |
| 2 | Active comparator | Not described Receives: Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.
Measured: baseline and 12 months
Secondary outcomes (1)
MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)
Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Kowa Company, Ltd.
- Responsible party
- Principal investigator, Hiroaki Kazui, Osaka University
- Investigators
- Hiroaki Kazui, Ph.D., Principal investigator, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548145
- Sponsor's protocol ID
- OSK-07098
- Acronym
- PIT-ROAD
- Status last verified
- May 2012
- First submitted
- 22 Oct 2007
- Last updated
- 14 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00548145
- Acronym / sponsor ID
- PIT-ROAD / OSK-07098
- Conditions
- Alzheimer Disease, Hypercholesterolemia
- Keywords
- Pitavastatin, Statins, Donepezil, Alzheimer's Disease, Hypercholesterolemia, ADAS-Jcog, Alzheimer Disease (MMSE 15-23 and CDR1 or 2)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Kowa Company, Ltd.
- Study start
- Nov 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Posted 14 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.
Detailed description
The PIT-ROAD study will include 50 patients who have taken donepezil more than 3 months stably. This study will see how the use of a particular statin medication, pitavastatin, affects ADAS-Jcog score etc. and cholesterol.
Participants will be given a full information of the study and written informed consent should be obtained before entering the study. Participants will take part in 5 visits over the course of 12 months. If participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. Participants will undergo 8 tests (ADAS-Jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pitavastatin |
| 2 | Active comparator | Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR "1" or "2")
- Patients with hypercholesterolemia
- Patients who have taken donepezil more than 3 months stably
- Both patients and care-givers must be more than 20 years old
Key exclusion criteria (9 listed)
- Women with pregnancy or breast-feeding
- Malignant tumor
- Cerebrovascular disorder or myocardial infarction prior to 12 weeks
- Heart failure [New York Heart Association (NYHA) class III or IV]
- Hepatic or renal dysfunction
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 |
|---|---|---|
| Pitavastatin2 mg by orally/day Duration: 12 months | Drug | 1 |
| cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)duration: 12 months | Drug | 2 |
Primary outcome
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
Time frame: baseline and 12 months
Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.
1 secondary outcome
MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
Hiroaki Kazui, Ph.D. principal investigator
Osaka University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pitavastatin and cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) in people with Alzheimer Disease and Hypercholesterolemia, run by Osaka University at 1 site in Japan.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jun 2012. 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 Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) (time frame: baseline and 12 months). 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 14 Jun 2012.