|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Toyama Chemical Co., Ltd. |
|---|---|
| Information provided by: | Toyama Chemical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00663936 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: T-817MA Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 326 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
T-817MA once daily
|
Drug: T-817MA
224 mg T-817 MA once daily
|
|
2: Placebo Comparator
Placebo once daily
|
Drug: Placebo
Placebo once daily
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jeremy Johnston | 1-800-554-0502 ext 294 | JJohnston@incresearch.com |
Hide Study Locations| United States, Arizona | |
| Northwest NeuroSpecialists | Recruiting |
| Tucson, Arizona, United States, 85741 | |
| Contact: Joan Laguna, CCRC 520-742-1833 jlaguna@neuroresearch.com | |
| Principal Investigator: Jeanette Wendt, MD | |
| Banner Alzheimer's Institute | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Stephanie Reeder 602-239-6279 stephanie.reeder@bannerhealth.com | |
| Principal Investigator: Pierre Tariot, M.D. | |
| United States, California | |
| San Francisco Clinical Research Center | Recruiting |
| San Francisco, California, United States, 94109 | |
| Contact: Michael Miller 415-673-4600 sfhaclin@aol.com | |
| Principal Investigator: Jerome Goldstein, MD | |
| Southwest Institute for Clinical Research, Inc. | Recruiting |
| Rancho Mirage, California, United States, 92270 | |
| Contact: Linda Roger, RN 760-464-2124 LRogerRN@aol.com | |
| Principal Investigator: Richard Hubbard, MD | |
| Pacific Research Network, Inc. | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Bud Gaydos, LVN 619-294-4302 bgaydos@prnsd.com | |
| Principal Investigator: Stephen G Thein, PhD | |
| United States, Colorado | |
| Radiant Research | Recruiting |
| Denver, Colorado, United States, 80239 | |
| Contact: Burlleen Hewitt 303-480-7122 burlleen.hewitt@radiantresearch.com | |
| Principal Investigator: Leslie Moldauer, MD | |
| United States, Connecticut | |
| Geriatric and Adult Psychiatry, LCC | Recruiting |
| Hamden, Connecticut, United States, 06518 | |
| Contact: Andrea DeClement 203-288-0414 adeclement@geriatrics-psych.com | |
| Principal Investigator: Alan Siegal, MD | |
| Research Center for Clinical Studies, Inc. | Recruiting |
| Norwalk, Connecticut, United States, 06851 | |
| Contact: Suman Thapamagar 203-838-0070 sthapamagar@rccsmail.com | |
| Principal Investigator: Bart A Sloan, M.D. | |
| United States, Florida | |
| Axiom Clinical Research of Florida | Recruiting |
| Tampa, Florida, United States, 33609 | |
| Contact: Kathleen Carlson 813-353-9613 kcarlson.axiom@verizon.net | |
| Principal Investigator: Susan J Steen, MD | |
| Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Marianne Chanti-Ketterl 813-396-0621 mchantik@health.usf.edu | |
| Principal Investigator: Ashok Raj, MD | |
| Premiere Research Institute | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Contact: Teresa Villena 561-845-0500 ext 142 tvillena@aol.com | |
| Principal Investigator: Carl Sadowsky, MD | |
| Renstar Medical Research | Recruiting |
| Ocala, Florida, United States, 34471 | |
| Contact: Pat Riddle 352-629-5800 renstar@renstar.net | |
| Principal Investigator: John P Nardandrea, M.D. | |
| NeuroPsychiatric Center of the Palm Beaches | Recruiting |
| Boynton Beach, Florida, United States, 33426 | |
| Contact: Jacqueline Taylor 561-364-7257 jtaylor@neuropsychofpb.com | |
| Principal Investigator: Veronica Motiram, M.D. | |
| Anchor Research Center | Recruiting |
| Naples, Florida, United States, 34102 | |
| Contact: Ginnie Hennes 239-643-8805 vhennes@anchorhealthcenters.com | |
| Principal Investigator: Ashley Tunkle, MD | |
| United States, Georgia | |
| Columbus Research & Wellness Institute | Recruiting |
| Columbus, Georgia, United States, 31907 | |
| Contact: Theresa Harris 706-653-0419 theresaharris10@hotmail.com | |
| Principal Investigator: Reinaldo Verson, MD | |
| United States, Indiana | |
| Agewell | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Rebecca Hancock, RN 317-846-9792 bhancock@agewell.biz | |
| Principal Investigator: Stephen Rappaport, MD | |
| United States, Nevada | |
| Cleveland Clinic - Lou Ruvo Center for Brain Health | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: Michelle Sholar 702-671-5058 sholarm@ccf.org | |
| Principal Investigator: Charles B Bernick, MD | |
| United States, New Jersey | |
| Memory Enhancement Center of America | Recruiting |
| Toms River, New Jersey, United States, 08755 | |
| Contact: Ashley Clayton 732-341-9500 aclayton@memorycenternj.com | |
| Principal Investigator: Joel S Ross, MD | |
| United States, New York | |
| Alzheimer's Disease Center, U. of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14620 | |
| Contact: Bonnie Goldstein 585-760-6561 BonnieS_Goldstein@URMC.rochester.edu | |
| Principal Investigator: Anton Porsteinsson, MD | |
| Richmond Behavioral Associates | Recruiting |
| Staten Island, New York, United States, 10312 | |
| Contact: Tatiana Kundla 718-317-5522 patakyova@rbany.com | |
| Principal Investigator: Mark DiBuono, MD | |
| Brooklyn Medical Institute | Recruiting |
| Brooklyn, New York, United States, 11214 | |
| Contact: Lilit Asatryan 718-339-7711 lasatryan@gminstitutes.com | |
| Principal Investigator: Zinoviy Benzar, MD Ph.D. | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Debra Heydt 919-668-2843 debra.heydt@duke.edu | |
| Principal Investigator: James Burke, M.D. | |
| Clinical Trials of America, Inc. | Recruiting |
| Winston Salem, North Carolina, United States, 27103 | |
| Contact: Kim Durkin 336-768-3456 kdurkin@ctamerica.net | |
| Principal Investigator: Beverly N Jones, III, M.D. | |
| The Alzheimer's Memory Center | Recruiting |
| Charlotte, North Carolina, United States, 28211 | |
| Contact: Michelle Herrin 704-364-4000 mherrin@carolinasresearch.com | |
| Principal Investigator: Mohammad Bolouri, MD | |
| Raleigh Neurology Associates | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Contact: Beth Jackson, LPN 919-782-3456 ext 8264 bjackson@raleighneurology.com | |
| Principal Investigator: Patricia Naslund, MD | |
| United States, Pennsylvania | |
| CRI Worldwide, LLC | Recruiting |
| Philadelphia, Pennsylvania, United States, 19139 | |
| Contact: Nicolette Laskowski 215-471-6859 nlaskowski@criww.com | |
| Principal Investigator: Daniel Gruener, M.D. | |
| United States, Texas | |
| Innovative Clinical Trials | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Elizabeth Hendrix 210-377-2873 Elizabeth.Hendrix@innovativeclincialtrials.com | |
| Principal Investigator: James E Garrison, MD | |
| United States, Wisconsin | |
| IPC Research | Recruiting |
| Waukesha, Wisconsin, United States, 53188 | |
| Contact: Anne Dobratz 262-513-0700 ext 230 annedobratz@sbcglobal.net | |
| Principal Investigator: Cary Kohlenberg, MD | |
| Canada, Ontario | |
| Toronto Memory Program | Recruiting |
| Toronto, Ontario, Canada, M3B 2S7 | |
| Contact: Atif Shaikh 416-386-9761 ashaikh@memorydisorders.ca | |
| Principal Investigator: Sharon Cohen, MD | |
More Information
| Responsible Party: | Toyama Chemical Co., Ltd. ( Dr. Katsumi Shimizu, Development Management Department ) |
| Study ID Numbers: | AA4437420 |
| Study First Received: | April 18, 2008 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00663936 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's Disease Alzheimer's |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |
