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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: CPC-201


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPC-201<br> | Drug: CPC-201<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donepezil Maximum Tolerated Dose (MTD) | Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any TEAEs | Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study. | 6 months | 
| Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose | Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance. | Day 1 (baseline) to end of study |