Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07

NCT02434666 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CPC-001-10
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).

Conditions

Dementia of the Alzheimer's Type

Outcome Measures

Primary Outcomes (1)

• safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)

  To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.

  6 months

Secondary Outcomes (1)

• safety and tolerability of CPC-201 20mg/day (adverse events)

  6 months

Study Arms (1)

CPC-201

EXPERIMENTAL

Drug: CPC-201

Interventions

CPC-201 DRUG

CPC-201

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
• Have safely completed 12 week maintenance phase of CPC-001-07 study.

You may not qualify if:

• Renal and hepatic dysfunction with:
• Total Bilirubin: \>1.5 x UNL AST: \>2.5 x UNL ALT: \>2.5 x UNL Serum Creatinine: \>1.5 x UNL Creatinine Clearance: \<30 mL/min (calculated by Cockcroft and Gault equation)
• History or presence of myasthenia.
• ECG findings of:
• Complete Left Bundle Branch Block; Ventricular pacing; 2nd degree or 3rd degree AV block; Atrial fibrillation or atrial flutter; HR \<45 or \>100; PR \>220 msec; or QTcF \>450 msec in male, \>470 msec in female
• Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
• 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.

Sponsors & Collaborators

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

Study Sites (5)

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

Quantum Laboratories, Inc. Memory Disorder Center

Pompano Beach, Florida, 33064, United States

Location

Premiere Research Institute Neuroscience

West Palm Beach, Florida, 33407, United States

Location

IU School of Medicine IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

Giles Cromwell, MD

Winston-Salem, North Carolina, 27103, 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

Study Officials

• Minako Koga

  Chase Pharmaceuticals

  STUDY DIRECTOR

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: April 28, 2015
• First Posted: May 5, 2015
• Study Start: January 8, 2015
• Primary Completion: October 18, 2016
• Study Completion: November 22, 2016
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

US (5)