Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07187141 | Nasal Protollin in Early Symptomatic Alzheimer's Disease | PHASE1 | COMPLETED | 16 | — | — | Nov 18, 2021 | Feb 21, 2023 | Sep 22, 2025 | 1 | United States |
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 Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) for the evaluation of toxicities and reactogenicity. Tolerability will be assessed by the degree of severity of both spontaneously reported and elicited symptoms and associated signs, systemically and at the site of administration following administration of nasal Protollin, if thought by the investigator to be related or possibly related to its administration.
| Arm | Type | Description |
|---|---|---|
| Cohort A | ACTIVE_COMPARATOR | Protollin 0.1 mg or placebo |
| Cohort B | ACTIVE_COMPARATOR | Protollin 0.5 mg or placebo |
| Cohort C | ACTIVE_COMPARATOR | Protollin 1.0 mg or placebo |
| Cohort D | ACTIVE_COMPARATOR | Protollin 1.5 mg or placebo |
| Name | Type | Description |
|---|---|---|
| Protollin | DRUG | 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. |
Inclusion Criteria: 1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines1 for Early Symptomatic Alzheimer's Disease and have a MMSE of 29-20. 2. Age between 60-85 years (inclusive). 3. Good general health with no disease expected to interfere with the study. 4. On a stable m...