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

NCT02185053 | Completed Phase 2 Results DMC

• 1 other identifier: CPC-001-07
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Subjects With Any TEAEs

  6 months

• Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose

  Day 1 (baseline) to end of study

Study Arms (1)

CPC-201

EXPERIMENTAL

Drug: CPC-201

Interventions

CPC-201 DRUG

CPC-201

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Chase Pharmaceuticals Corporation, an affiliate of Allergan plc: lead

Study Sites (1)

CPC1

West Palm Beach, Florida, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Lynn James

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 9, 2014
• Study Start: July 31, 2014
• Primary Completion: July 31, 2016
• Study Completion: July 31, 2016
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2018-10

Locations

US (1)