Alzheimer's DiseasePhase 2NCT01120002
Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease
A Phase 2 study testing Tamibarotene in people with Alzheimer's Disease, run by Osaka City University at 1 site in Japan.
Trial summary
A double blind, placebo-controlled randomized study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Tamibarotene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- May 2010to Dec 2012
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients who are diagnosed as probable Alzheimer' Disease according to NINCDS-ADRDA criteria
- Diagnosed by brain diagnostic imaging (CT, MRI) within six months before the consent and no occurrence of the event after that to suggest cerebral vascular disease
- Mild to Moderate Alzheimer's Disease of MMSE from 10 to 26
- Age from 55 to 80
- Treated for a minimum of 12 weeks with a stable dose of donepezil and willing to continue the same during the trial period
- For women Menopause ≥ 2 years
Show all 10Show fewer
- For men contraceptive measures are required during the study and after 6 months
- In principle patients should be living at their home in the presence of a caregiver who is defined as a healthy person in contact with the patient for more than 10 hours a week, could provide required information of the behavior and activities of daily living, accompany all the clinical examination, and supervise the handling and administration of the drug throughout the study period.
- Patients who could take pills as a whole
- Patient, caregiver and patient surrogate are able and willing to comply with study visits and procedures per protocol, understand, sign, and date the written voluntary informed consent form
Who cannot join
- Any cause of dementia not due to Alzheimer's disease
- Past history of other central nervous condition or psychiatric disease
- Symptom of depression and drug addiction
- Impairment in the physical function by other factor than the Alzheimer's Disease
- Patients who are expected to move in to care facilities during the study period
- triglyceride > 400 mg/dL
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka City University Hospital
Osaka, 545-8586
Center for Drug&Food Clinical Evaluation, +81-6-6645-344, morikka@med.osaka-cu.ac.jp
About this study
A double blind, placebo-controlled randomized study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Alzheimer's Disease
Read the detailed description
Tamibarotene is a synthetic retinoid presently approved in Japan for the treatment of APL, which has a higher receptor selectivity and activity for the Retinoic Acid Receptor subtypes compared to the natural retinoid.
Tamibarotene decreased insoluble amyloid-beta (Ab) 42 deposition in APP mice, and also increased TTR, VAChT and ACh in the brain of SAMP8 mice, which suggest the enhancement of neurotransmission. In the behavioral model such as reduced anxiety of SAMP8 mice and rat passive avoidance test, tamibarotene showed improvement.
Tamibarotene as in other retinoids are known to moderate the immune system and reduce inflammatory cytokines and chemokines, which may control the excessive stimulation of astrocyte and microglia around the Ab plaque. Tamibarotene reduced cytokines and showed clinical efficacy in the rat experimental autoimmune encephalitis model.
Furthermore, retinoids are known to have critical roles during the regeneration stage in the differentiation from neural stem cells (NSC).
In spinal cord injured rats treated with tamibarotene showed better recovery compared to the control.
By these preclinical results, we plan by this study to evaluate the efficacy together with the safety of tamibarotene to the patients of Alzheimer's Disease.
Tamibarotene is used clinically in Japan since 2005. It's side effects are known to be similar to that of other clinically used retinoids.
- Conditions
- Alzheimer's Disease
- Being tested
- Tamibarotene, Placebo
- Keywords
- mild to moderate 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.
TamibaroteneDrug
Two Tamibarotene 2 mg or placebo tablet per day, once daily.
PlaceboDrug
Two Tamibarotene 2 mg or placebo tablet per day, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill | Placebo comparator | Not described Receives: Drug: Placebo |
| Tamibarotene | Active comparator | Not described Receives: Drug: Tamibarotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog)
Measured: baseline, 12 weeks, 24 weeks
Secondary outcomes (3)
Changes in Mini-Mental State Examination (MMSE)
Measured: baseline, 12 weeks, 24 weeks
Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Measured: baseline, 12 weeks, 24 weeks
Changes in Clinician Interview-Based Assessment of Change Plus Caregiver Information (CIBIC-Plus)
Measured: baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka City University
- Sponsor type
- University, hospital or other
- Investigators
- Takami Miki, M.D., Principal investigator, Department of Geriatrics and Neurology, Osaka City University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120002
- Sponsor's protocol ID
- OAM80-01
- Status last verified
- Jul 2011
- First submitted
- 30 Apr 2010
- Last updated
- 22 Jul 2011
- Results posted
- No
Publications
Shudo K, Fukasawa H, Nakagomi M, Yamagata N. Towards retinoid therapy for Alzheimer's disease. Curr Alzheimer Res. 2009 Jun;6(3):302-11. doi: 10.2174/156720509788486581.
PubMed 19519313
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01120002
- Acronym / sponsor ID
- OAM80-01
- Conditions
- Alzheimer's Disease
- Keywords
- mild to moderate Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Osaka City UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 May 2010 (estimated)
- 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.
A double blind, placebo-controlled randomized study to evaluate the efficacy and safety of orally administered Tamibarotene to patients of Alzheimer's Disease
Detailed description
Tamibarotene is a synthetic retinoid presently approved in Japan for the treatment of APL, which has a higher receptor selectivity and activity for the Retinoic Acid Receptor subtypes compared to the natural retinoid.
Tamibarotene decreased insoluble amyloid-beta (Ab) 42 deposition in APP mice, and also increased TTR, VAChT and ACh in the brain of SAMP8 mice, which suggest the enhancement of neurotransmission. In the behavioral model such as reduced anxiety of SAMP8 mice and rat passive avoidance test, tamibarotene showed improvement.
Tamibarotene as in other retinoids are known to moderate the immune system and reduce inflammatory cytokines and chemokines, which may control the excessive stimulation of astrocyte and microglia around the Ab plaque. Tamibarotene reduced cytokines and showed clinical efficacy in the rat experimental autoimmune encephalitis model.
Furthermore, retinoids are known to have critical roles during the regeneration stage in the differentiation from neural stem cells (NSC).
In spinal cord injured rats treated with tamibarotene showed better recovery compared to the control.
By these preclinical results, we plan by this study to evaluate the efficacy together with the safety of tamibarotene to the patients of Alzheimer's Disease.
Tamibarotene is used clinically in Japan since 2005. It's side effects are known to be similar to that of other clinically used retinoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pill | Placebo comparator | Drug: Placebo |
| Tamibarotene | Active comparator | Drug: Tamibarotene |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Japanese patients who are diagnosed as probable Alzheimer' Disease according to NINCDS-ADRDA criteria
- Diagnosed by brain diagnostic imaging (CT, MRI) within six months before the consent and no occurrence of the event after that to suggest cerebral vascular disease
- Mild to Moderate Alzheimer's Disease of MMSE from 10 to 26
- Age from 55 to 80
- Treated for a minimum of 12 weeks with a stable dose of donepezil and willing to continue the same during the trial period
Key exclusion criteria (6 listed)
- Any cause of dementia not due to Alzheimer's disease
- Past history of other central nervous condition or psychiatric disease
- Symptom of depression and drug addiction
- Impairment in the physical function by other factor than the Alzheimer's Disease
- Patients who are expected to move in to care facilities during the study period
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 |
|---|---|---|
| TamibaroteneTwo Tamibarotene 2 mg or placebo tablet per day, once daily. | Drug | Tamibarotene |
| PlaceboTwo Tamibarotene 2 mg or placebo tablet per day, once daily. | Drug | Placebo pill |
Primary outcome
Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog)
Time frame: baseline, 12 weeks, 24 weeks
3 secondary outcomes
Changes in Mini-Mental State Examination (MMSE)
Time frame: baseline, 12 weeks, 24 weeks
Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: baseline, 12 weeks, 24 weeks
Changes in Clinician Interview-Based Assessment of Change Plus Caregiver Information (CIBIC-Plus)
Time frame: baseline, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Background: PubMed 19519313Shudo K, Fukasawa H, Nakagomi M, Yamagata N. Towards retinoid therapy for Alzheimer's disease. Curr Alzheimer Res. 2009 Jun;6(3):302-11. doi: 10.2174/156720509788486581.
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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.
Takami Miki, M.D. principal investigator
Department of Geriatrics and Neurology, Osaka City University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamibarotene in people with Alzheimer's Disease, run by Osaka City 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 10 inclusion and 6 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 22 Jul 2011. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takami Miki, MD (+81-6-6645-212, ""miki."@med.osaka-cu.ac.jp"), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog) (time frame: baseline, 12 weeks, 24 weeks). 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 NCT01120002, which also lists 1 linked publication.
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 22 Jul 2011.