Status:
COMPLETED
Nasal Protollin in Early Symptomatic Alzheimer's Disease
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
I-Mab Biopharma US Limited
Conditions:
Alzheimer Disease (AD)
Eligibility:
All Genders
60-85 years
Phase:
PHASE1
Brief 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 tolerabi...
Detailed Description
In this research study investigators want to learn more about a new drug called nasal Protollin as a possible new treatment for Alzheimer's Disease (AD). In AD, there is accumulation in the brain of a...
Eligibility Criteria
Inclusion
- 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.
- Age between 60-85 years (inclusive).
- Good general health with no disease expected to interfere with the study.
- On a stable medication regimen for 8 weeks prior to the study and which is anticipated to remain stable during the study.
- Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile). ). If a woman is of childbearing potential, her partner is required to use contraception throughout the study (for those identifying as male).
- Amyloid-positive PET scan (if subject meets all other inclusion criteria).
- Ability to understand and provide informed consent.
Exclusion
- Any significant neurologic disease including Parkinson's disease, multi-infarct dementia, Huntington's disease, frontotemporal dementia, Lewy body dementia, normal pressure hydrocephalus, brain tumor, brain hemorrhage with persistent neurologic deficits, progressive supra-nuclear palsy, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease.
- History of autoimmune disease.
- Current treatment with immunomodulatory or immunosuppressive drugs, or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month.
- Major depression or bipolar disorder or a history of schizophrenia.
- History of alcohol or substance abuse or dependence within the past 2 years.
- History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
- Clinically significant abnormalities (defined as greater than mild on the FDA's vaccine toxicity scale) in screening laboratories.
- Participation in another clinical trial of an investigational drug concurrently or within the past 30 days.
- Active COVID-19 disease
- Amyloid-negative PET scan (at screening)
- COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing)
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07187141
Start Date
November 18 2021
End Date
February 21 2023
Last Update
September 22 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115