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CompletedPhase 2Results posted

A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia

A Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients With Alzheimer's Disease Type Dementia

Asset

CPC-201

Listed sites

1

Recruiting sites

-

Enrollment

41

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20

Primary endpoint

•Donepezil Maximum Tolerated Dose (MTD)

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-001-07
NCT IDNCT02185053

Timeline

Milestones

Study first posted2014-07-09estimated
Study start2014-07-31actual
Primary completion2016-07-31actual
Study completion2016-07-31actual
Last update posted2020-06-04actual
Results first posted2020-06-04actual

Assets

Drug assets

CPC-201

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age79 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Aged 50 - 79 years inclusive.
•Meeting the diagnosis of probable Alzheimer's Disease
•Of moderate severity (Mini-Mental Status Exam [MMSE] score 10 - 20 inclusive).
•Patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests

Exclusion criteria

•Women of child bearing potential.
•History or presence of a seizure disorder.
•History of 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.
•History or presence of myasthenia.
•Known hypersensitivity to donepezil, solifenacin or related drugs.
•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.

Endpoints (6)

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
4
Other (unclassified)
2

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Number of Subjects With Any TEAEs

Time frame:6 months

event count, event

Secondary/protocol endpoint

Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose

Time frame:Day 1 (baseline) to end of study

concentration, descriptive

Secondary/registry result

Number of Subjects With Any TEAEs

Time frame:6 months

event count, event

Posted result

GroupValue (number), ParticipantsReported bounds
Safety PopulationSerious Adverse Events (SAEs)n=41 Participants8-
Non-serious AEsn=41 Participants34-
Deathsn=41 Participants1-
Secondary/registry result

Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose

Time frame:Day 1 (baseline) to end of study

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
Solifenain Dose EscalationDonepezil Concentration pre-dose (ng/mL)n=41 Participants42.720.27
Donepezil Concentration 4 hour post-dose (ng/mL)n=41 Participants57.221.58
Donepezil Dose EscalationDonepezil Concentration pre-dose (ng/mL)n=32 Participants184.265.95
Donepezil Concentration 4 hour post-dose (ng/mL)n=32 Participants257.580.56
Donepezil Dose MaintenanceDonepezil Concentration pre-dose (ng/mL)n=29 Participants188.164.21
Donepezil Concentration 4 hour post-dose (ng/mL)n=29 Participants269.280.94

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Donepezil Maximum Tolerated Dose (MTD)

Time frame:6 months

event count, event

Primary/registry result/low confidence

Donepezil Maximum Tolerated Dose (MTD)

Time frame:6 months

event count, event

Posted result

GroupValue (number), ParticipantsReported bounds
Donepezil Dose Escalation15 mg/dayn=33 Participants0-
20 mg/dayn=33 Participants0-
25 mg/dayn=33 Participants2-
30 mg/dayn=33 Participants1-
35 mg/dayn=33 Participants1-
40 mg/dayn=33 Participants29-
Donepezil Dose Maintenance15 mg/dayn=33 Participants0-
20 mg/dayn=33 Participants0-
25 mg/dayn=33 Participants2-
30 mg/dayn=33 Participants2-
35 mg/dayn=33 Participants1-
40 mg/dayn=33 Participants28-

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.