A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia

Completed · Phase 2

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02185053

Run by

Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

People needed

41

Starts

2014-07-31

Expected to finish

2016-07-31

Last updated by the study team

2020-06-04

Who can join

Age: 50 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CPC1 — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

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