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Could a nasal spray fight Alzheimer's? early trial begins

NCT ID NCT07187141

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

16 people

The number who actually took part.

Started

Nov 2021

Finished

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

60 to 85 years

Sex

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.