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

NCT01120002 | Unknown Phase 2

• 1 other identifier: OAM80-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer's Disease

Keywords

mild to moderate Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

  baseline, 12 weeks, 24 weeks

Secondary Outcomes (3)

• Changes in Mini-Mental State Examination (MMSE)

  baseline, 12 weeks, 24 weeks

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

  baseline, 12 weeks, 24 weeks

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

  baseline, 12 weeks, 24 weeks

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

Drug: Placebo

Tamibarotene

ACTIVE COMPARATOR

Drug: Tamibarotene

Interventions

Tamibarotene DRUG

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

Tamibarotene

Placebo DRUG

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

Placebo pill

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka City University: lead

Study Sites (1)

Osaka City University Hospital

Osaka, 545-8586, Japan

RECRUITING

Related Publications (1)

• 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.

  PMID: 19519313 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tamibarotene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Takami Miki, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takami Miki, MD

CONTACT

+81-6-6645-212; ""miki."@med.osaka-cu.ac.jp"

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

JP (1)