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Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
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
Asset
CPC-201
Listed sites
5
Recruiting sites
-
Enrollment
21
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 50-89
Primary endpoint
•Safety and tolerability of the maximum tolerated dose (MTD) of CPC-201
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. 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.
2. Have safely completed 12 week maintenance phase of CPC-001-07 study
Exclusion criteria
1. 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)
2. History or presence of myasthenia.
3. 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
4. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
5. 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.
Endpoints (2)
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.
Safety / tolerability / PK
2 endpointssafety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)
Time frame:6 months
event count, event
safety and tolerability of CPC-201 20mg/day (adverse events)
Time frame:6 months
event count, event
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.