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Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
T-817MA
Placebo
Sponsored by
FUJIFILM Toyama Chemical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Alzheimer's

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female (post-menopausal or surgically sterile)
  2. Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil.
  3. Age 50 to 90 inclusive
  4. Patients must be living in the community
  5. Patients must have an eligible informant or study partner (caregiver)
  6. Patients and eligible informant or study partner (caregiver) must be able to read and understand English.
  7. Informed consent obtained from both the patient and the caregiver etc (According to the protocol)

Exclusion Criteria:

  1. Patients with clinically significant cardiac, hepatic or renal impairment
  2. Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
  3. Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).

Sites / Locations

  • Banner Alzheimer's Institute
  • Northwest NeuroSpecialists
  • Collaborative Neuroscience Network, Inc.
  • Southwest Institute for Clinical Research, Inc.
  • Pacific Research Network, Inc.
  • San Francisco Clinical Research Center
  • Radiant Research
  • Geriatric and Adult Psychiatry, LCC
  • Research Center for Clinical Studies, Inc.
  • NeuroPsychiatric Center of the Palm Beaches
  • Galiz Research
  • Anchor Research Center
  • Renstar Medical Research
  • Axiom Clinical Research of Florida
  • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
  • Premiere Research Institute
  • Columbus Research & Wellness Institute
  • Agewell
  • Cleveland Clinic - Lou Ruvo Center for Brain Health
  • Comprehensive Clinical Research
  • Memory Enhancement Center of America
  • Brooklyn Medical Institute
  • SPRI Clinical Trials
  • Alzheimer's Disease Center, U. of Rochester Medical Center
  • Richmond Behavioral Associates
  • The Alzheimer's Memory Center
  • Duke University Medical Center
  • Raleigh Neurology Associates
  • Clinical Trials of America, Inc.
  • The Clinical Trials Center
  • CRI Worldwide, LLC
  • Innovative Clinical Trials
  • IPC Research
  • St. Joseph's Hospital
  • Toronto Memory Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

T-817MA once daily

Placebo once daily

Outcomes

Primary Outcome Measures

Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.

Secondary Outcome Measures

Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.

Full Information

First Posted
April 18, 2008
Last Updated
October 9, 2013
Sponsor
FUJIFILM Toyama Chemical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00663936
Brief Title
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
Official Title
A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FUJIFILM Toyama Chemical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, Alzheimer's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
T-817MA once daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
T-817MA
Intervention Description
224 mg T-817 MA once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female (post-menopausal or surgically sterile) Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil. Age 50 to 90 inclusive Patients must be living in the community Patients must have an eligible informant or study partner (caregiver) Patients and eligible informant or study partner (caregiver) must be able to read and understand English. Informed consent obtained from both the patient and the caregiver etc (According to the protocol) Exclusion Criteria: Patients with clinically significant cardiac, hepatic or renal impairment Patient have a dementia not of the Alzheimer's type etc (According to the protocol) Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Northwest NeuroSpecialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Southwest Institute for Clinical Research, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Geriatric and Adult Psychiatry, LCC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
NeuroPsychiatric Center of the Palm Beaches
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Galiz Research
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Columbus Research & Wellness Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31907
Country
United States
Facility Name
Agewell
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cleveland Clinic - Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Memory Enhancement Center of America
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Brooklyn Medical Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
SPRI Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Alzheimer's Disease Center, U. of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
The Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Clinical Trials Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
St. Joseph's Hospital
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3L6
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada

12. IPD Sharing Statement

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Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

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