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NCT07187141 · ClinicalTrials.gov registry record · Phase 1
Nasal Protollin in Early Symptomatic Alzheimer's Disease
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT07187141: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT07187141 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07187141, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
In this research study investigators aim to learn more about a new drug called Protollin as a possible new treatment for Alzheimer's Disease (AD). The primary goal is to assess the safety and tolerability.
Primary Outcome
Safety and tolerability of ascending doses of nasal Protollin following administration of two doses one week apart in subjects, 60-85 years inclusive with Early Symptomatic Alzheimer's Disease (29-20 MMSE classification). Safety will be assessed by physical examination (including evaluation of the nose and oropharynx), laboratory studies, EKG, and elicited and spontaneously reported signs and symptoms, using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent V
Interventions
- DRUG Protollin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 1 |
What the finished NCT07187141 record still lists
NCT07187141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Protollin is the first listed.
NCT07187141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07187141 about?
NCT07187141 is a clinical study titled "Nasal Protollin in Early Symptomatic Alzheimer's Disease". In this research study investigators aim to learn more about a new drug called Protollin as a possible new treatment for Alzheimer's Disease (AD). The primary goal is to assess the safety and tolerability.
What is the current status of trial NCT07187141?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-11-18. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT07187141?
The interventions under investigation include: Protollin (DRUG).
Who is sponsoring clinical trial NCT07187141?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07187141's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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