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

Chase Therapeutics

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: CPC-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT02185053

CPC-001-07

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

50 to 79 years old

Volunteers

No Healthy Volunteers

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.