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CPC-201

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Trials Updated: Jun 4, 2020

CPC-201 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jul 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

CPC-201 clinical trials

CPC-201 · 2 trials · 2 indications

Phase 2 2
NCT02434666Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07Dementia of the Alzheimer's Type
COMPLETED21 Analytics
NCT02185053A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type DementiaAlzheimer's Disease
COMPLETED41 Analytics
PHASE2COMPLETED
Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
Dementia of the Alzheimer's TypeUnlock trial analytics
PHASE2COMPLETED
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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

To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.

Donepezil Maximum Tolerated Dose (MTD)
6 months

Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.

Secondary Endpoints

safety and tolerability of CPC-201 20mg/day (adverse events)
6 months
Number of Subjects With Any TEAEs
6 months
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
Day 1 (baseline) to end of study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CPC-201EXPERIMENTAL -

Interventions

NameTypeDescription
CPC-201DRUG -
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Eligibility Criteria

Age Range50 Years to 89 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 c...

Countries:United States
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Frequently asked questions about CPC-201

What is CPC-201 used for?

CPC-201 is an investigational small molecule being studied for Alzheimer's disease and dementia of the Alzheimer's type. It has been evaluated in Phase 2 clinical trials in patients aged 50 years and older. It is not approved for any indication and remains in clinical development.

Who is developing CPC-201?

CPC-201 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor behind the clinical program evaluating CPC-201 in Alzheimer's disease and dementia of the Alzheimer's type.

What phase is CPC-201 in?

CPC-201 is in Phase 2 development. Two Phase 2 trials have been conducted, both of which are now completed. The program has not advanced beyond Phase 2, and CPC-201 is investigational rather than approved.

What clinical trials is CPC-201 in?

CPC-201 has been studied in two completed Phase 2 trials: NCT02185053, a Phase II study of CPC-201 in Alzheimer's disease type dementia, and NCT02434666, a long term extension safety study in patients with dementia of the Alzheimer's type who completed study CPC-001-07. Both were conducted in the United States.

How many patients were enrolled in CPC-201 trials?

The CPC-201 Phase 2 program enrolled 41 patients in NCT02185053 and 21 patients in the extension study NCT02434666. Both trials were uncontrolled, were not randomized, and were not double blinded, and they enrolled patients aged 50 years and older.