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CPC-12

CompletedPhase 2Results posted

A 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 diseaseMMSE 7-24Study 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

Org study IDCPC-001-12
NCT IDNCT02549196

Timeline

Milestones

Study first posted2015-09-15estimated
Study start2015-10-07actual
Primary completion2017-09-28actual
Study completion2017-09-28actual
Last update posted2019-03-05actual
Results first posted2019-03-05actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age89 Years
SexAll
Healthy volunteersNot accepted

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:

-Revised National Institute on Aging-Alzheimer's Disease Association (NIA-ADA) criteria and
-Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria.

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:

-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)

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:

-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

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

-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.

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
Other (unclassified)
2

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Number of Participants With TEAEs Leading to Study Drug Discontinuation

Time frame:1-7 weeks

event count, event

Secondary/registry result

Number of Participants With TEAEs Leading to Study Drug Discontinuation

Time frame:1-7 weeks

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Cohort 1n=8 Participants2-
Cohort 2n=1 Participants0-
Cohort 1bn=6 Participants1-
Cohort 3cn=13 Participants4-

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:1-7 weeks

threshold achievement, improvement

Primary/registry result/low confidence

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

Time frame:1-7 weeks

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Cohort 1n=7 Participants2-
Cohort 2n=1 Participants0-
Cohort 1bn=5 Participants1-
Cohort 3cn=12 Participants6-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.