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Dementia of Alzheimer's TypePhase 2CPC-12NCT02549196

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

A Phase 2 study testing Donepezil and Solifenacin in people with Dementia of Alzheimer's Type, run by Chase Pharmaceuticals Corporation, an affiliate of Allergan plc at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
Dementia of Alzheimer's Type
What is being tested?
Donepezil and Solifenacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
4 sitesUnited States
Study dates
7 Oct 2015to 28 Sep 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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:
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  • 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.
  • History of substance abuse, known drug addiction, or positive test for drugs of abuse or alcohol.
  • Patients treated with the following medications within 8 weeks of screening
  • AChEIs (other than donepezil),
  • Peripherally acting anticholinergics (such as drugs for the treatment of overactive bladder disorder),
  • Psychoactive medications (including antipsychotics, antidepressants, anxiolytics or sedative hypnotics) having significant anticholinergic effects and/or believed to affect cognitive function.
  • Other medications are acceptable, at the investigators discretion, if dosage is held stable for at least 4 weeks prior to screening and throughout the study.
  • Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
  • Patients hospitalized within 4 weeks of screening.
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Quantum Laboratories

    Deerfield Beach, Florida, 33064

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • PMG Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase II, Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type

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.

Read the detailed description

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. The study involves a step wise cohort design in two different patient populations: Group 1 will comprise of patients who have been treated with low dose of CPC-201(5 or 10 mg/day) (given once daily) for at least 4 weeks just prior to Day1. Group 2 will consist of patients who have never been treated with CPC-201 before or who have not received any other AChEI for the past 6 months.

In this study, CPC-201 dose will be increased at weekly intervals, in accordance with the schedules given below, to its first intolerable dose (FID) or maximum allowed dose (MAD) of 60 mg/day (40mg/day for Cohort 3c) together with solifenacin 15 mg/day.

Cohort 1 1st week: 20mg 2nd week: 30mg 3rd week: 40mg 4th week: 50mg 5th week: 60mg Cohort 2* 1st week: 20mg 2nd week: 40mg 3rd week: 60mg Cohort 1b 1st - 2nd week: 10mg 3rd week: 20mg 4th week: 30mg 5th week: 40mg 6th week: 50mg 7th week: 60mg Cohort 3c* 1st week: 10mg 2nd week: 15mg 3rd week: 20mg 4th week: 25mg 5th week: 30mg 6th week: 35mg 7th week: 40mg

*: The dose titration schedule of Cohort 2 and 3 may be altered based on Cohort 1 result.

Patients will be enrolled in Cohort 2 only when patients enrolled in Cohort 1 have safely completed titration. Similary, patients will be enrolled in Cohort 3, only when patients enrolled in Cohort 2 have safely completed titration.

Patients reaching their FID or having completed one week treatment with donepezil 40mg/day, have two options.

Option 1: Patient will be allowed to immediately enter a long term extension at their Maximum tolerated dose (MTD) or MAD.

Option 2: Patients may choose not to enter the long term extension, in which case the Investigator will decide whether the patient should discontinue high dose of donepezil without down-titration, or whether donepezil should be downtitrated to their own standard of donepezil dose.

Being tested
Donepezil, Solifenacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonepezilDrug

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

  • SolifenacinDrug

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

Study groups in NCT02549196
Study groupRoleWhat they receive
Cohort 1ExperimentalDonepezil 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.
Receives: Drug: Donepezil; Drug: Solifenacin
Cohort 2ExperimentalDonepezil 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.
Receives: Drug: Donepezil; Drug: Solifenacin
Cohort 1bExperimentalDonepezil 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.
Receives: Drug: Donepezil; Drug: Solifenacin
Cohort 3cExperimentalDonepezil 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.
Receives: Drug: Donepezil; Drug: Solifenacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-7 weeks

Secondary outcomes (1)

  1. Number of Participants With TEAEs Leading to Study Drug Discontinuation

    Number of subjects who experienced any treatment-emergent adverse events (TEAEs) leading to study drug discontinuation

    Measured: 1-7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2015 (estimated)
  2. Study start7 Oct 2015
  3. Primary completion28 Sep 2017
  4. Study completion28 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02549196
Sponsor's protocol ID
CPC-001-12
Acronym
CPC-12
Status last verified
Feb 2019
First submitted
27 Aug 2015
Last updated
5 Mar 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donepezil and Solifenacin in people with Dementia of Alzheimer's Type, run by Chase Pharmaceuticals Corporation, an affiliate of Allergan plc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort (time frame: 1-7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02549196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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