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

• Status: Completed
• Trial end date: 2016-07-31
• Target enrollment: 0
• Participant gender: All

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 Dementia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chase Pharmaceuticals Corporation; Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

Criteria

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.