Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 55 - 85 |
| Updated: | 2/28/2019 |
| Start Date: | March 2014 |
| End Date: | May 5, 2017 |
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
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).
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).
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®)
We found this trial at
50
sites
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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1295 North Martin Avenue
Tucson, Arizona 85721
Tucson, Arizona 85721
(520) 626-1197
University of Arizona Health Sciences Center The Arizona Health Sciences Center (AHSC) at the University...
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