Nasal stem cell spray could slow Alzheimer's – first human test begins
NCT ID NCT07554872
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether a nasal spray containing particles from neural stem cells is safe for people with moderate-to-severe early-onset Alzheimer's. Nine participants aged 50-75 will receive different dosing schedules over 28 days. The main goal is to check for side effects, but researchers will also look for signs of cognitive improvement.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: * Male or postmenopausal female, aged 50 to 75 years. * Meets the 2011 NIA-AA criteria for probable Alzheimer's disease dementia. * Age at onset ≤65 years. * CMMS score 5-20 * Stable dose for at least 2 months before enrollment if receiving pro-cognitive or psychiatric medications. * Primary school education or above and able to complete study-required cognitive assessments. * Hachinski Ischemic Score ≤4. * GDS-30 total score ≤10. * Screening brain MRI+DWI+SWI meeting protocol-defined cerebrovascular exclusion thresholds and no major structural abnormalities inconsistent with Alzheimer's disease. * Positive amyloid pathology confirmed by Aβ-PET at screening or before enrollment. * Adequate vision and hearing to complete assessments. * Has a reliable caregiver able to accompany the participant to study visits and provide information for assessments. * Willing to participate and sign informed consent. Exclusion Criteria: * Dementia due to causes other than Alzheimer's disease. * Brain MRI showing any of the following: Fazekas white matter hyperintensity score \>2; more than 2 lacunar infarcts \>1.5 cm; lacunar infarcts involving critical regions such as the thalamus, hippocampus, entorhinal cortex, or parahippocampal region; cerebral hemorrhage, subdural hematoma, aneurysm, arteriovenous malformation, intracranial mass lesion, or other clinically significant structural abnormalities. * Allergy to stem cell-derived exosomes or PET examination. * Severe psychiatric disorder or symptoms. * Significant active physical illness, including severe cardiac disease, severe systemic infection, or severe liver/kidney dysfunction. * Elevated tumor markers or tumor history. * Immune-related disease. * Significant nasal obstruction. * Serious suicide risk. * Participation in another clinical trial or stem cell therapy within the past 6 months. * Any other condition judged inappropriate by the investigator. * Contraindications to MRI or inability to complete MRI examinations, including non-MRI-compatible metallic implants, certain stents, plates, pacemakers, or severe claustrophobia.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
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Other studies related to the condition(s) this trial covers.
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