A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 50 - 79 |
Updated: | 7/27/2016 |
Start Date: | July 2014 |
End Date: | July 2016 |
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 Dementia
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 Dementia.
Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with
Alzheimer's Disease Type Dementia.
Inclusion Criteria:
- 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 Criteria:
- 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.
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