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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: Completed Phase 1 study, sponsored by AZTherapies.
NCT04570644 is a Phase 1 study that has completed, run by AZTherapies. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
• PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF
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 |
What the finished NCT04570644 record still lists
NCT04570644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04570644's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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