Dementia of the Alzheimer's TypePhase 2NCT02434666
Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
A Phase 2 study testing CPC-201 in people with Dementia of the Alzheimer's Type, run by Chase Pharmaceuticals Corporation, an affiliate of Allergan plc at 5 sites in United States.
Trial summary
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07). Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Dementia of the Alzheimer's Type
- What is being tested?
- CPC-201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jan 2015to 22 Nov 2016
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
- Have safely completed 12 week maintenance phase of CPC-001-07 study.
Who cannot join
- 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.
- 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
- Patients considered unlikely to co-operate 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
IU School of Medicine IU Health Neuroscience Center
Indianapolis, Indiana, 46202
Miami Jewish Health Systems
Miami, Florida, 33137
Quantum Laboratories, Inc. Memory Disorder Center
Pompano Beach, Florida, 33064
Premiere Research Institute Neuroscience
West Palm Beach, Florida, 33407
Giles Cromwell, MD
Winston-Salem, North Carolina, 27103
About this study
Official title: Safety and Tolerability of CPC-201 in Patients With Dementia of the Alzheimer's Type Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).
Read the detailed description
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07). Patients having safely completed the 12-week maintenance phase of Study CPC-001-07 will be eligible for admission. Subjects will remain on their CPC-201 MTD as determined in Study CPC-001-07. The dose of CPC-201 will be increased from 15 mg/day (administered in Study CPC-001-07) to 20mg/day starting on Day1. For those patients who do not tolerate 20mg/day CPC-201, the dose of CPC-201will be decreased to its previously tolerated level of 15mg/day.
This protocol allows to increase patients' MTD of CPC-201, as previously determined in the Phase II Study (CPC-001-07 protocol) by, 5mg or 10mg increment up to a maximum of 60 mg/day starting on Day7 or Month 3 visits of this extension protocol per Investigator's judgment and patient's tolerability.
This extension study is intended to continue for each enrolled patient for up to 6 months unless medically contraindicated. Patients may withdraw from this study at any time. Upon termination of this study, patients will return to their original daily donepezil dose of 10 mg/day and will continue to receive CPC-201 mg/day for one final week.
- Conditions
- Dementia of the Alzheimer's Type
- Being tested
- CPC-201
- 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
| Study group | Role | What they receive |
|---|---|---|
| CPC-201 | Experimental | Not described Receives: Drug: CPC-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
Measured: 6 months
Secondary outcomes (1)
safety and tolerability of CPC-201 20mg/day (adverse events)
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
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 posted5 May 2015 (estimated)
- Study start8 Jan 2015
- Primary completion18 Oct 2016
- Study completion22 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia of the Alzheimer's TypeStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minako Koga, Study director, Chase Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434666
- Sponsor's protocol ID
- CPC-001-10
- Status last verified
- Sep 2017
- First submitted
- 28 Apr 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of CPC-201 in Patients With Dementia of the Alzheimer's Type Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
- ClinicalTrials.gov ID
- NCT02434666
- Acronym / sponsor ID
- CPC-001-10
- Conditions
- Dementia of the Alzheimer's Type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chase Pharmaceuticals Corporation, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2015 (actual)
- Primary completion
- 18 Oct 2016 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 5 May 2015 (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.
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).
Detailed description
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07). Patients having safely completed the 12-week maintenance phase of Study CPC-001-07 will be eligible for admission. Subjects will remain on their CPC-201 MTD as determined in Study CPC-001-07. The dose of CPC-201 will be increased from 15 mg/day (administered in Study CPC-001-07) to 20mg/day starting on Day1. For those patients who do not tolerate 20mg/day CPC-201, the dose of CPC-201will be decreased to its previously tolerated level of 15mg/day.
This protocol allows to increase patients' MTD of CPC-201, as previously determined in the Phase II Study (CPC-001-07 protocol) by, 5mg or 10mg increment up to a maximum of 60 mg/day starting on Day7 or Month 3 visits of this extension protocol per Investigator's judgment and patient's tolerability.
This extension study is intended to continue for each enrolled patient for up to 6 months unless medically contraindicated. Patients may withdraw from this study at any time. Upon termination of this study, patients will return to their original daily donepezil dose of 10 mg/day and will continue to receive CPC-201 mg/day for one final week.
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 |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
- Have safely completed 12 week maintenance phase of CPC-001-07 study.
Key exclusion criteria (7 listed)
- 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.
- 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
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-201 | Drug | CPC-201 |
Primary outcome
safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)
Time frame: 6 months
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
1 secondary outcome
safety and tolerability of CPC-201 20mg/day (adverse events)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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.
Minako Koga study director
Chase Pharmaceuticals
5 sites 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 in people with Dementia of the Alzheimer's Type, run by Chase Pharmaceuticals Corporation, an affiliate of Allergan plc at 5 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 2 inclusion and 7 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 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events) (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 20 Sep 2017.