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Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Tamibarotene

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring mild to moderate Alzheimer's Disease

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Sites / Locations

Osaka City University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo pill

Tamibarotene

Arm Description

Outcomes

Primary Outcome Measures

Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog)

Secondary Outcome Measures

Changes in Mini-Mental State Examination (MMSE)

Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Changes in Clinician Interview-Based Assessment of Change Plus Caregiver Information (CIBIC-Plus)

Full Information

NCT ID

NCT01120002

First Posted

April 30, 2010

Last Updated

July 21, 2011

Sponsor

Osaka City University

1. Study Identification

Unique Protocol Identification Number

NCT01120002

Brief Title

Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Osaka City University

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

mild to moderate Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo pill

Arm Type

Placebo Comparator

Arm Title

Tamibarotene

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tamibarotene

Intervention Description

Two Tamibarotene 2 mg or placebo tablet per day, once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Two Tamibarotene 2 mg or placebo tablet per day, once daily.

Primary Outcome Measure Information:

Title

Changes in Alzheimer's Disease Assessment Scale (ADAS-JCog)

Time Frame

baseline, 12 weeks, 24 weeks

Secondary Outcome Measure Information:

Title

Changes in Mini-Mental State Examination (MMSE)

Time Frame

baseline, 12 weeks, 24 weeks

Title

Changes in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time Frame

baseline, 12 weeks, 24 weeks

Title

Changes in Clinician Interview-Based Assessment of Change Plus Caregiver Information (CIBIC-Plus)

Time Frame

baseline, 12 weeks, 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Takami Miki, MD

Phone

+81-6-6645-212

""miki."@med.osaka-cu.ac.jp"

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takami Miki, M.D.

Organizational Affiliation

Department of Geriatrics and Neurology, Osaka City University Graduate School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Osaka City University Hospital

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Center for Drug&Food Clinical Evaluation

Phone

+81-6-6645-344

morikka@med.osaka-cu.ac.jp

12. IPD Sharing Statement

Citations:

PubMed Identifier

19519313

Citation

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.

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Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Disease

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