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CPC-12
CompletedPhase 2Results postedA Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type
A Phase II, Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type
Assets
Donepezil / Solifenacin
Listed sites
4
Recruiting sites
-
Enrollment
28
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 7-24•Study partner/caregiver required
Primary endpoint
•Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Signed an Institutional Review Board (IRB) approved informed consent document
2. Aged 50 - 89 years inclusive.
3. Meeting the diagnosis of probable AD consistent with:
4. Mild to severe severity (Mini-Mental Status Exam [MMSE] scores 7 - 24 inclusive).
5. Rosen-Modified Hachinski Ischemia Score of ≤4.
6. Have a suitable caregiver to supervise the at-home administration of study drugs and observe for AEs.
7. 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;
8. 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.
9. Patients in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests
Exclusion criteria
1. Women of child bearing potential.
2. History or presence of a seizure disorder.
3. Current unstable peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
4. History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
5. History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
6. Renal and hepatic dysfunction with:
7. History or presence of myasthenia.
8. History or family history of Prolonged QT Syndrome.
9. History of unexplained syncope or family history of unexplained syncope or sudden death.
10. Myocardial infarction or hospitalization for congestive heart failure within 6 months.
11. ECG findings of:
12. Known hypersensitivity to donepezil, solifenacin or related drugs.
13. History of drug significant allergy.
14. History of substance abuse, known drug addiction, or positive test for drugs of abuse or alcohol.
15. Patients treated with the following medications within 8 weeks of screening
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.
16. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
17. Patients hospitalized within 4 weeks of screening.
18. 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.
19. Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
2 endpointsNumber of Participants With TEAEs Leading to Study Drug Discontinuation
Time frame:1-7 weeks
event count, event
Number of Participants With TEAEs Leading to Study Drug Discontinuation
Time frame:1-7 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Cohort 1n=8 Participants | 2 | - |
| Cohort 2n=1 Participants | 0 | - |
| Cohort 1bn=6 Participants | 1 | - |
| Cohort 3cn=13 Participants | 4 | - |
Other (unclassified)
2 endpointsNumber of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort
Time frame:1-7 weeks
threshold achievement, improvement
Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort
Time frame:1-7 weeks
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Cohort 1n=7 Participants | 2 | - |
| Cohort 2n=1 Participants | 0 | - |
| Cohort 1bn=5 Participants | 1 | - |
| Cohort 3cn=12 Participants | 6 | - |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.