New brain scan could spot Alzheimer's earlier
NCT ID NCT07580703
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a radioactive tracer called [18F]Flortaucipir, used during a PET scan to detect tau protein tangles in the brain—a hallmark of Alzheimer's disease. Researchers will enroll 18 Chinese adults aged 50-85 with normal cognition, mild cognitive impairment, or Alzheimer's to check the tracer's safety, how it moves through the body, and how well it spots disease signs. The goal is to see if this imaging method can help diagnose Alzheimer's more accurately.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]Flortaucipir Injection (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could improve early detection of Alzheimer's disease by showing tau protein buildup in the brain.
- What could go wrong
- This is a very early Phase I study with only 18 participants, so results may not apply broadly. The tracer involves radiation exposure, and its diagnostic accuracy is still unproven.
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 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Signed informed consent form (ICF). * Male or female aged 50-85 years. * Education level sufficient to cooperate with neuropsychological testing and obtain reliable results. * Meet the following criteria related to cognitive impairment: 1. CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes. 2. MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes. 3. AD: Meet core criteria for probable AD dementia, Aβ-PET positive, MRI showing neurodegenerative changes. * Fertile individuals: No plan for reproduction, sperm/egg donation within 6 months after signing ICF and until 6 months after study drug administration; and agreement to use highly effective contraception (including partner). Exclusion Criteria: * Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women. * Major surgery within 1 month prior to screening, or planned surgery during the study period. * Known allergy to radioactive radiation, alcohol, \[18F\]Flortaucipir injection, or its excipients, or other severe allergic reactions. * Cognitive impairment due to causes other than AD. * Clinically significant infarction or probable multi-infarct dementia. * Current clinically significant psychiatric illness (e.g., major depression, schizophrenia). * History of epilepsy or seizures (except febrile seizures in childhood). * Inability to tolerate PET/MRI or presence of contraindications to PET/MRI. * Other neurodegenerative diseases or dementias other than AD dementia. * Any other condition that, in the investigator's opinion, makes the subject unsuitable for the study.
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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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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
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