Status:
COMPLETED
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Lead Sponsor:
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-79 years
Phase:
PHASE2
Brief Summary
This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type D...
Eligibility Criteria
Inclusion
- Aged 50 - 79 years inclusive.
- Meeting the diagnosis of probable Alzheimer's Disease
- Of moderate severity (Mini-Mental Status Exam \[MMSE\] score 10 - 20 inclusive).
- Patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.
Exclusion
- Women of child bearing potential.
- History or presence of a seizure disorder.
- History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
- History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
- History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History or presence of myasthenia.
- Known hypersensitivity to donepezil, solifenacin or related drugs.
- Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
Key Trial Info
Start Date :
July 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02185053
Start Date
July 31 2014
End Date
July 31 2016
Last Update
June 4 2020
Active Locations (1)
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1
CPC1
West Palm Beach, Florida, United States