Alzheimer's DiseasePhase 2NCT02860065
CPC-201 Alzheimer's Disease Type Dementia: PET Study
A Phase 2 study testing CPC-201 and Positron emission tomography (PET) in people with Alzheimer's Disease, run by Chase Pharmaceuticals Corporation, an affiliate of Allergan plc at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CPC-201 and Positron emission tomography (PET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2016to 30 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 79 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 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.
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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.
- 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.
Who cannot join
- 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
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- 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.
- ECG findings of:
- Complete Left Bundle Branch block;
- Ventricular pacing;
- 2nd degree or 3rd degree AV block;
- Atrial fibrillation or atrial flutter;
- Heart rate <45 or >100;
- PR >220 msec; or
- QTcF >450 msec in male, >470 msec in female
- 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.
- Claustrophobia
- Patients considered unlikely to cooperate 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.
- Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Health System--West Bloomfield Hospital
West Bloomfield, Michigan, 48322
About this study
Official title: Phase II, Modified Single-Blind, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Cerebral Efficacy of CPC-201 in Patients With Alzheimer's Disease Type Dementia: PET Study
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).
Read the detailed description
Patients will continue on the 10 mg/day dose of donepezil with the addition of 15 mg/day of solifenacin at least for a week, donepezil will be titrated from 10 to 50 mg/day (maximum allowed dose; MAD) or each patient's MTD with increments of 5 or 10 mg weekly or bi-weekly as medically appropriate. When the MTD or MAD of donepezil co-administered with solifenacin 15 mg/day as CPC-201 has been reached, treatment will be stably maintained, as tolerated, for 3 months.
Patients successfully completing this protocol will have the option of continuing in an open extension of their CPC-201 treatment (separate protocol) or returned to their pre-admission therapeutic regimen and discharged from the study.
On the days of study drug dose increase, patients will be evaluated at a clinic as an out-patient.
This is a sequential study conducted in 6 phases in AD patients who had previously been receiving donepezil at a dose of 10 mg/day:
- Screening
- Baseline assessment
- Solifenacin introduction at a dose of 15 mg/day (given with continued donepezil 10 mg/day as CPC-201);
- Donepezil dose escalation to each subject's MTD or 50 mg/day (MAD), given in combination with solifenacin 15 mg/day as CPC-201;
- Donepezil maintenance at its MTD (or MAD) combined with solifenacin 15 mg/day as CPC-201 for 3 months;
- Protocol exit (after resumption of pre-study treatment regimen and successful completion of a one month post-study safety check) or optional entry into a 6 month extension phase.
Baseline assessment (during solifenacin introduction): Upon successful completion of a screening evaluation and entry into this study, participants will continue to receive 10 mg donepezil and receive neuropsychological evaluations at the clinic together with a 11C-PMP PET scan and associated MRI studies of the brain in accordance with the University of Michigan.
Solifenacin introduction: After the one week baseline assessment period, solifenacin treatment will be initiated at 15 mg/day for at least one week while patients continue to receive donepezil at a dose of 10 mg/day. Those who do not tolerate solifenacin will be withdrawn from the study and replaced.
Donepezil escalation: During this phase, while continuing to receive 15 mg/day of solifenacin, the dose of donepezil will be gradually increased at weekly or bi-weekly with increments of 5 or 10 mg as tolerated. The dose of donepezil will be increased until the first intolerable dose (FID) is reached or a dose of 50 mg/day is attained, whichever comes first. Once patients reach their FID, their MTD will be defined as their immediately preceding, tolerated dose. During dose titration, investigators may extend the same donepezil dose for additional days or temporarily (or permanently) reduce it as medically indicated. On the days of donepezil dose increase, patients will remain in the clinic for at least 5 hours after study drug administration or until signs and symptoms of medically significant adverse effects abate.
Donepezil dose maintenance: During this phase, patients will continue treatment with donepezil (at MTD) and solifenacin (15 mg/day) for 3 months (± 2 weeks). All will be followed by weekly telephone interviews and monthly clinic visits to assess safety and tolerability. If intolerable adverse events (AEs) develop, the daily dose of donepezil will be down-titrated, and the patient will continue treatment on their new MTD for an additional 2 weeks or up to completion of the maintenance phase, whichever comes last. Patients who continue to experience intolerable AEs after several down-titrations will be withdrawn from the study.
End of study testing at the end of donepezil dose maintenance: After completion of 3-months (± 2 weeks) treatment with donepezil (at MTD) and solifenacin (15 mg/day), study participants will receive a repeat of their clinical examination, routine laboratory safety tests and PET associated studies.
Patients successfully completing this protocol will then have the option of continuing in an open extension of their CPC-201 treatment (separate protocol) or to be returned to their pre-admission therapeutic regimen and discharged from the study.
Study Exit: Upon termination of this study, subjects will return to their original daily donepezil dose. Investigator will decide whether the patient should discontinue high dose of donepezil without down-titration, or whether donepezil should be down-titrated to their prestudy donepezil dose. Whatever the decision, the patient will ordinarily be treated at least an additional 7 days with solifenacin 15 mg/day.
- Conditions
- Alzheimer's Disease
- Being tested
- CPC-201, Positron emission tomography (PET)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC-201Drug
solifenacin and donepezil
Positron emission tomography (PET)Other
measure activity of cerebral acetylcholinesterase
| Study group | Role | What they receive |
|---|---|---|
| CPC-201 | Experimental | combination of solifenacin and high doses of donepezil Receives: Drug: CPC-201; Other: Positron emission tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donepezil Maximum tolerated dose (MTD) change on imaging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start30 Sep 2016 (estimated)
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860065
- Sponsor's protocol ID
- CPC-001-15
- Status last verified
- Aug 2017
- First submitted
- 26 Jul 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Modified Single-Blind, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Cerebral Efficacy of CPC-201 in Patients With Alzheimer's Disease Type Dementia: PET Study
- ClinicalTrials.gov ID
- NCT02860065
- Acronym / sponsor ID
- CPC-001-15
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chase Pharmaceuticals Corporation, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2016 (estimated)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients will continue on the 10 mg/day dose of donepezil with the addition of 15 mg/day of solifenacin at least for a week, donepezil will be titrated from 10 to 50 mg/day (maximum allowed dose; MAD) or each patient's MTD with increments of 5 or 10 mg weekly or bi-weekly as medically appropriate. When the MTD or MAD of donepezil co-administered with solifenacin 15 mg/day as CPC-201 has been reached, treatment will be stably maintained, as tolerated, for 3 months.
Patients successfully completing this protocol will have the option of continuing in an open extension of their CPC-201 treatment (separate protocol) or returned to their pre-admission therapeutic regimen and discharged from the study.
On the days of study drug dose increase, patients will be evaluated at a clinic as an out-patient.
This is a sequential study conducted in 6 phases in AD patients who had previously been receiving donepezil at a dose of 10 mg/day:
- Screening
- Baseline assessment
- Solifenacin introduction at a dose of 15 mg/day (given with continued donepezil 10 mg/day as CPC-201);
- Donepezil dose escalation to each subject's MTD or 50 mg/day (MAD), given in combination with solifenacin 15 mg/day as CPC-201;
- Donepezil maintenance at its MTD (or MAD) combined with solifenacin 15 mg/day as CPC-201 for 3 months;
- Protocol exit (after resumption of pre-study treatment regimen and successful completion of a one month post-study safety check) or optional entry into a 6 month extension phase.
Baseline assessment (during solifenacin introduction): Upon successful completion of a screening evaluation and entry into this study, participants will continue to receive 10 mg donepezil and receive neuropsychological evaluations at the clinic together with a 11C-PMP PET scan and associated MRI studies of the brain in accordance with the University of Michigan.
Solifenacin introduction: After the one week baseline assessment period, solifenacin treatment will be initiated at 15 mg/day for at least one week while patients continue to receive donepezil at a dose of 10 mg/day. Those who do not tolerate solifenacin will be withdrawn from the study and replaced.
Donepezil escalation: During this phase, while continuing to receive 15 mg/day of solifenacin, the dose of donepezil will be gradually increased at weekly or bi-weekly with increments of 5 or 10 mg as tolerated. The dose of donepezil will be increased until the first intolerable dose (FID) is reached or a dose of 50 mg/day is attained, whichever comes first. Once patients reach their FID, their MTD will be defined as their immediately preceding, tolerated dose. During dose titration, investigators may extend the same donepezil dose for additional days or temporarily (or permanently) reduce it as medically indicated. On the days of donepezil dose increase, patients will remain in the clinic for at least 5 hours after study drug administration or until signs and symptoms of medically significant adverse effects abate.
Donepezil dose maintenance: During this phase, patients will continue treatment with donepezil (at MTD) and solifenacin (15 mg/day) for 3 months (± 2 weeks). All will be followed by weekly telephone interviews and monthly clinic visits to assess safety and tolerability. If intolerable adverse events (AEs) develop, the daily dose of donepezil will be down-titrated, and the patient will continue treatment on their new MTD for an additional 2 weeks or up to completion of the maintenance phase, whichever comes last. Patients who continue to experience intolerable AEs after several down-titrations will be withdrawn from the study.
End of study testing at the end of donepezil dose maintenance: After completion of 3-months (± 2 weeks) treatment with donepezil (at MTD) and solifenacin (15 mg/day), study participants will receive a repeat of their clinical examination, routine laboratory safety tests and PET associated studies.
Patients successfully completing this protocol will then have the option of continuing in an open extension of their CPC-201 treatment (separate protocol) or to be returned to their pre-admission therapeutic regimen and discharged from the study.
Study Exit: Upon termination of this study, subjects will return to their original daily donepezil dose. Investigator will decide whether the patient should discontinue high dose of donepezil without down-titration, or whether donepezil should be down-titrated to their prestudy donepezil dose. Whatever the decision, the patient will ordinarily be treated at least an additional 7 days with solifenacin 15 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPC-201 | Experimental | Drug: CPC-201, Other: Positron emission tomography (PET)combination of solifenacin and high doses of donepezil |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Of mild to moderate severity: Mini-Mental Status Exam (MMSE) score 10 - 24 inclusive.
- Rosen-Modified Hachinski Ischemia Score of ≤4.
Key exclusion criteria (32 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPC-201solifenacin and donepezil | Drug | CPC-201 |
| Positron emission tomography (PET)measure activity of cerebral acetylcholinesterase | Other | CPC-201 |
Primary outcome
Donepezil Maximum tolerated dose (MTD) change on imaging
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPC-201 and Positron emission tomography (PET) in people with Alzheimer's Disease, run by Chase Pharmaceuticals Corporation, an affiliate of Allergan plc at 1 site 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 10 inclusion and 32 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: withdrawn, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Donepezil Maximum tolerated dose (MTD) change on imaging (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2017.