NCT02549196

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

4 active sites

Status
completed

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

August 27, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

October 7, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

August 27, 2015

Results QC Date

September 28, 2018

Last Update Submit

February 12, 2019

Conditions

Dementia of Alzheimer's Type

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort

    Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen.

    1-7 weeks

Secondary Outcomes (1)

  • Number of Participants With TEAEs Leading to Study Drug Discontinuation

    1-7 weeks

Study Arms (4)

Cohort 1

EXPERIMENTAL

Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.

Drug: DonepezilDrug: Solifenacin

Cohort 2

EXPERIMENTAL

Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.

Drug: DonepezilDrug: Solifenacin

Cohort 1b

EXPERIMENTAL

Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.

Drug: DonepezilDrug: Solifenacin

Cohort 3c

EXPERIMENTAL

Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.

Drug: DonepezilDrug: Solifenacin

Interventions

DonepezilDRUG

Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin.

Cohort 1Cohort 1bCohort 2Cohort 3c
SolifenacinDRUG

Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin.

Cohort 1Cohort 1bCohort 2Cohort 3c

Eligibility Criteria

Age50 Years - 89 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
  • 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.
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Quantum Laboratories

Deerfield Beach, Florida, 33064, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

PMG Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Interventions

DonepezilSolifenacin Succinate

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan, Inc
IR-CTRegistration@allergan.com
714-246-4500

Study Officials

  • Lynn James

    Allergan

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 15, 2015

Study Start

October 7, 2015

Primary Completion

September 28, 2017

Study Completion

September 28, 2017

Last Updated

March 5, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-02

Locations

US(4)