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NCT04570644 · ClinicalTrials.gov registry record · Phase 1
Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers
A Phase 1 study, sponsored by AZTherapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT04570644 is a Phase 1 study that has completed, run by AZTherapies. The registered enrollment target is 56 participants.
The verdict
NCT04570644, a Phase 1 study, has completed, sponsored by AZTherapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.
Interventions
- DRUG ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2021-01-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04570644
The ClinicalTrials.gov registry entry for NCT04570644 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AZTherapies, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) is the first listed.
NCT04570644 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04570644 about?
NCT04570644 is a clinical study titled "Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers". This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-adminis...
What is the current status of trial NCT04570644?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-08-28. Estimated completion is 2021-01-18.
What interventions are being tested in trial NCT04570644?
The interventions under investigation include: ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) (DRUG).
Who is sponsoring clinical trial NCT04570644?
This trial is sponsored by AZTherapies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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