Clinical trial NCT02079909: Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Official title: A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Alzheimer's
Lead sponsor: FUJIFILM Toyama Chemical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Alzheimer's Disease Cooperative Study (ADCS)
First posted: 2014-03-06
Enrollment: 482
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC.

The secondary objectives are:

* To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events.
* To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).


Eligibility criteria: Inclusion Criteria:

* Male or female (post-menopausal or surgically sterile)
* Patients with Mild to moderate Alzheimer's disease who are receiving donepezil (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.
* Age 55 to 85 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

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 or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)

Primary outcomes:
measure: ADAS-cog Change From Baseline to Week 52
timeFrame: Baseline and 52 weeks
measure: CGIC
timeFrame: 52 weeks
Secondary outcomes:
measure: ADCS-ADL Change From Baseline to Week 52
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: La Jolla
country: United States
facility: UCSD Comprehensive Alzheimer's Program
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Hamden
country: United States
facility: Geriatric and Adult Psychiatry, LCC
state: Connecticut
city: New Haven
country: United States
facility: Yale University, Alzheimer's Disease Research Unit
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Clinical Research Unit
state: District of Columbia
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami Miller-School of Medicine
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Neuro Trials Research, Inc
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Elkhart
country: United States
facility: Indiana Medical Research
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Partners, Adult Neurology Clinic
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Fairway
country: United States
facility: University of Kansas/Clinical and Translational Science Unit
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Sanders-Brown Center on Aging Clinic
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Bangor
country: United States
facility: Acadia Hospital
state: Maine
city: Boston
country: United States
facility: Boston University Alzheimer's Disease Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System/ Michigan Clinical Research Unit
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Paw Paw
country: United States
facility: Bronson Neurobehvioral Health
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center(Geri Psych)
state: Nebraska
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Princeton
country: United States
facility: Global Medical Institutes, LLC;Princeton Medical Institute
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: New York
country: United States
facility: Alzheimer's Disease Research Center of Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center Sergievsky Center Taub Institute
state: New York
city: Orangeburg
country: United States
facility: The Nathan S. Kline Instituite for Psychiatric Research
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University (WFU) School of Medicine
state: North Carolina
city: Beachwood
country: United States
facility: Case Western Reserve University/ University Hospitals Case Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania, Penn Memory Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Alzheimer Disease Research Center
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates, LTD.
state: Pennsylvania
city: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center -VUIIS
state: Tennessee
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Waukesha
country: United States
facility: Cary J. Kohlenberg MD., SC dba IPC Research
state: Wisconsin
Study officials:
References:
citation: Schneider LS, Thomas RG, Hendrix S, Rissman RA, Brewer JB, Salmon DP, Oltersdorf T, Okuda T, Feldman HH; Alzheimer's Disease Cooperative Study TCAD Study Group. Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2019 Nov 1;76(11):1330-1339. doi: 10.1001/jamaneurol.2019.1868.