CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Protollindrug
Likely dose
Protollin 1.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07187141
NCT07187141Phase 1Completed
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Phase I Study of the Safety, Tolerability, and Immune Effects of Nasal Protollin in Subjects With Early Symptomatic Alzheimer's Disease

Brigham and Women's Hospital·interventional·Posted Sep 22, 2025·Updated Sep 22, 2025

In Brief

A Phase 1 clinical trial evaluating Protollin for Alzheimer Disease (AD). Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease (AD)
CountriesUnited States
CollaboratorsI-Mab Biopharma US Limited

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedSep 22, 2025
Enrollment StartNov 18, 2021
Primary CompletionSep 22, 2022
Study CompletionFeb 21, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9 months ago

Interventions

Protollindrug

For the 0.1, 0.5, and 1.0 mg dose groups, Protollin (450 μL per vial) in an aqueous buffer will be administered in two, 0.1 μL sprays, one per nostril. For the 1.5 mg dose group, Protollin (450 muL per vial) in an aqueous buffer will be administered in three, 0.1 μL sprays, two in one nostril and one in the other nostril.