A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type

Completed · Phase 2

Conditions studied: Dementia of Alzheimer's Type

In brief

This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's type to determine the optimal dose titration schedule.

Key facts

Study ID

NCT02549196

Run by

Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

People needed

28

Starts

2015-10-07

Expected to finish

2017-09-28

Last updated by the study team

2019-03-05

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed an Institutional Review Board (IRB) approved informed consent document
• Aged 50 - 89 years inclusive.
• Meeting the diagnosis of probable AD consistent with:
• Revised National Institute on Aging-Alzheimer's Disease Association (NIA-ADA) criteria and
• Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria.
• Mild to severe severity (Mini-Mental Status Exam [MMSE] scores 7 - 24 inclusive).
• Rosen-Modified Hachinski Ischemia Score of ≤4.
• Have a suitable caregiver to supervise the at-home administration of study drugs and observe for AEs.
• Patients treated with donepezil 5 or 10 mg/day (given once daily) for at least 4 weeks just prior to Day1 for Population (group) 1 or;
• Patients never been treated with donepezil before (donepezil naïve) or who have not received any other AChEI for the past 6 months for Population (group) 2.
• Patients 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.
• Current unstable 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.
• 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.
• History or family history of Prolonged QT Syndrome.
• History of unexplained syncope or family history of unexplained syncope or sudden death.
• Myocardial infarction or hospitalization for congestive heart failure within 6 months.
• 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
• Known hypersensitivity to donepezil, solifenacin or related drugs.
• History of drug significant allergy.

Where it is running

• Quantum Laboratories — Deerfield Beach, Florida, United States
• Miami Jewish Health Systems — Miami, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• PMG Research — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.