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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185053
• Other study ID #: CPC-001-07
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2014
• Est. completion date: July 31, 2016

Study information

• Verified date: October 2018
• Source: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 31, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• CPC-201

Locations

Country	Name	City	State
United States	CPC1	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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