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

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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.


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.
We found this trial at
1
site
West Palm Beach, Florida
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West Palm Beach, FL
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