Could a nasal spray fight Alzheimer's? early trial begins
NCT ID NCT07187141
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early study tested a nasal spray called Protollin in 16 people with early Alzheimer's disease. The main goal was to see if it is safe and tolerable. The spray is designed to boost the immune system in the brain, possibly helping to clear away harmful proteins linked to Alzheimer's.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Protollin (nasal spray)
- What this could lead to
- If safe and effective, this could point toward a new way to treat Alzheimer's by stimulating the immune system to clear harmful proteins from the brain.
- What could go wrong
- This is a very early, small Phase 1 trial focused only on safety, not on whether the drug works. Many promising early treatments fail in later, larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Feb 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 medication regimen for 8 weeks prior to the study and which is anticipated to remain stable during the study. 5. 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). 6. Amyloid-positive PET scan (if subject meets all other inclusion criteria). 7. Ability to understand and provide informed consent. Exclusion Criteria: 1. 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. 2. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease. 3. History of autoimmune disease. 4. Current treatment with immunomodulatory or immunosuppressive drugs, or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month. 5. Major depression or bipolar disorder or a history of schizophrenia. 6. History of alcohol or substance abuse or dependence within the past 2 years. 7. 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. 8. Clinically significant abnormalities (defined as greater than mild on the FDA's vaccine toxicity scale) in screening laboratories. 9. Participation in another clinical trial of an investigational drug concurrently or within the past 30 days. 10. Active COVID-19 disease 11. Amyloid-negative PET scan (at screening) 12. COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Other studies related to the condition(s) this trial covers.
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