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CPC-201 Alzheimer's Disease Type Dementia: PET Study
Phase II, Modified Single-Blind, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Cerebral Efficacy of CPC-201 in Patients With Alzheimer's Disease Type Dementia: PET Study
Asset
CPC-201
Listed sites
1
Recruiting sites
-
Enrollment
-
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 10-24•Study partner/caregiver required
Primary endpoint
•Donepezil Maximum tolerated dose (MTD) change on imaging
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. Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study protocol and are willing to participate in the study and comply with all its procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate their eligibility for the study.
2. Aged 50 - 79 years inclusive.
3. Meet the diagnosis of probable AD consistent with:
4. Of mild to moderate severity: Mini-Mental Status Exam (MMSE) score 10 - 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. Treated with donepezil 10 mg/day (given once daily) for at least 4 weeks just prior to study entry and to have safely tolerated, as judged clinically by the investigator.
8. 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
1. Women of child bearing potential.
2. History or presence of a seizure disorder.
3. History of uncontrolled peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
4. History or presence of uncontrolled bladder outflow obstruction, gastrointestinal obstructive disorder or reduced gastrointestinal motility, or narrow-angle glaucoma.
5. Renal and hepatic dysfunction with:
6. History or presence of myasthenia.
7. History of Prolonged QT Syndrome.
8. History of unexplained syncope.
9. Myocardial infarction or hospitalization for congestive heart failure within 6 months.
10. Patients has implanted cardiac pacemaker, implantable cardiac defibrillator (ICD), or metallic objects located in the eye, neck, ear, brain or blood vessel walls.
11. ECG findings of:
12. Patients treated with the following medications within 8 weeks of screening
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.
13. Claustrophobia
14. Patients considered unlikely to cooperate in the study, and/or poor compliance anticipated by the investigator.
15. 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.
16. Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
Endpoints (1)
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.
Other (unclassified)
1 endpointDonepezil Maximum tolerated dose (MTD) change on imaging
Time frame:6 months
descriptive
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.