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CompletedPhase 2

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

Org study IDCPC-001-10
NCT IDNCT02434666

Timeline

Milestones

Study start2015-01-08actual
Study first posted2015-05-05estimated
Primary completion2016-10-18actual
Study completion2016-11-22actual
Last update posted2017-09-20actual

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. 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 endpoints
Primary/protocol endpoint

safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)

Time frame:6 months

event count, event

Secondary/protocol endpoint

safety and tolerability of CPC-201 20mg/day (adverse events)

Time frame:6 months

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.