Nasal spray of stem cell 'Messages' could slow rare brain disease
NCT ID NCT07638813
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This study tests a new nasal spray treatment for frontotemporal dementia (FTD), a brain disease that changes personality and language. The spray contains tiny particles from umbilical cord stem cells that may protect brain cells and reduce harmful protein buildup. About 33 adults with FTD will receive either the spray or a placebo to see if it is safe and can slow the disease. Currently, there is no cure for FTD, so this treatment aims to control the disease rather than eliminate it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 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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30 to 80 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: 1. Diagnosis of probable frontotemporal dementia (FTD), including behavioral variant (bvFTD), semantic variant primary progressive aphasia (svPPA), or non-fluent variant primary progressive aphasia (nfvPPA), according to established diagnostic criteria, with supportive neuroimaging evidence showing frontal and/or temporal lobe atrophy score of 2 or higher on brain CT or MRI. 2. Age between 30 and 80 years (inclusive) at screening. 3. Study partner who agrees to participate in the study, provides at least 3 hours of daily care or visits, and can manage all study medication. 4. Frontotemporal Lobar Degeneration Clinical Dementia Rating (FTLD-CDR) score of 0-2 and Mini-Mental State Examination (MMSE) score greater than 10 at screening. 5. Stable use of cognition- or behavior-related medications (e.g., cholinesterase inhibitors, memantine, antidepressants, antipsychotics, mood stabilizers, benzodiazepines) for at least 30 days before baseline. 6. Signed informed consent form. Exclusion Criteria: 1. History of stroke or other neurological or psychiatric disorder (other than FTD) that is considered the primary cause of behavioral symptoms. 2. Pregnancy or breastfeeding, or plan to become pregnant during the study period. 3. Use of any investigational or experimental drug or device within 60 days or 5 half-lives (whichever is longer) prior to screening. 4. Presence of speech or language impairment that severely affects the implementation of neuropsychological assessments or safety evaluations per the study protocol. 5. History of cancer, unless: (a) considered cured; (b) not actively receiving anti-cancer therapy or radiation and the investigator judges that treatment is unlikely to be needed in the next 5 years; or (c) for prostate cancer or basal cell carcinoma, no significant progression in the past 2 years. 6. Any clinically significant hematologic, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease that would interfere with study participation. Participants may be included if the condition has been stable for at least one year and the investigator judges that it does not affect participation. 7. Known hypersensitivity to the study drug or any of its excipients.
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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
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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
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