NCT02860065

Brief Summary

The purpose of this study is to compare the effect of low and high dose CPC-201 on brain function including cerebral acetylcholinesterase (AChE) activity measured by positron emission tomography (PET).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

July 26, 2016

Last Update Submit

August 8, 2017

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Donepezil Maximum tolerated dose (MTD) change on imaging

    6 months

Study Arms (1)

CPC-201

EXPERIMENTAL

combination of solifenacin and high doses of donepezil

Drug: CPC-201Other: Positron emission tomography (PET)

Interventions

CPC-201DRUG

solifenacin and donepezil

CPC-201
Positron emission tomography (PET)OTHER

measure activity of cerebral acetylcholinesterase

CPC-201

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study protocol and are willing to participate in the study and comply with all its procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate their eligibility for the study.
  • Aged 50 - 79 years inclusive.
  • Meet the diagnosis of probable AD consistent with:
  • Revised National Institute on Aging-Alzheimer's Association (NIA-ADA) criteria and
  • Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria.
  • Of mild to moderate severity: Mini-Mental Status Exam (MMSE) score 10 - 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.
  • Treated with donepezil 10 mg/day (given once daily) for at least 4 weeks just prior to study entry and to have safely tolerated, as judged clinically by the investigator.
  • 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 uncontrolled peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
  • History or presence of uncontrolled bladder outflow obstruction, gastrointestinal obstructive disorder or reduced gastrointestinal motility, or narrow-angle glaucoma.
  • 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 of Prolonged QT Syndrome.
  • History of unexplained syncope.
  • Myocardial infarction or hospitalization for congestive heart failure within 6 months.
  • Patients has implanted cardiac pacemaker, implantable cardiac defibrillator (ICD), or metallic objects located in the eye, neck, ear, brain or blood vessel walls.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System--West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques
0

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 26, 2016

First Posted

August 9, 2016

Study Start

September 30, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

US(1)