New PET dye could spot Alzheimer's early in the brain
NCT ID NCT07422857
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new injection called [18F]-APN-1607 that helps a PET scan see harmful tau tangles in the brain, which are linked to Alzheimer's disease. About 316 adults aged 50 and older with normal memory, mild memory problems, or Alzheimer's dementia will get the injection and a brain scan. The goal is to see how well the scan can tell who has Alzheimer's-related changes, which could lead to earlier and more accurate diagnosis.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 316 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 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 years and older
- 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: 1. Subjects must be able to understand and voluntarily sign a written informed consent form (ICF); 2. Age ≥ 50 years, regardless of gender; 3. Subjects with HV, MCI, and AD should meet the clinical diagnostic criteria 4. Can tolerate brain MRI and PET imaging examinations; 5. For women of potential fertility (not yet menopausal or within 2 years of menopause), effective contraception must be used during the study and for 3 months after the study (effective contraception refers to sterilization, intrauterine hormonal devices, condoms, birth control pills, abstinence, or partner vasectomy, etc.); male participants should agree to use contraception during the study and for 3 months after the study. Exclusion Criteria: 1. Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria 2. Possible presence of frontotemporal degeneration (FTLD), characterized by progressive psych behavioral abnormalities and executive dysfunction,Characterized primarily by impairment and language function, progressive aphasia 3. The core symptoms of Lewy body dementia include fluctuating cognitive changes accompanied by significant attention and arousal abnormalities, recurrent typical visual hallucinations, and spontaneous symptoms of Parkinson's syndrome; 4. Currently suffering from significant mental illness. Subjects with accompanying psychiatric symptoms need to be carefully evaluated by the researchers to determine whether they can complete the imaging process; 5. Brain structural abnormalities confirmed by MRI, such as large strokes (infarct area greater than 4 cm) or intracranial space-occupying lesions; 6. Suffering from claustrophobia or unable to tolerate imaging procedures for other reasons; 7. History of alcohol or drug abuse/dependency; 8. Hypersensitivity to the investigational drug or any of its components; 9. Currently pregnant or breastfeeding; 10. Received non-vaccine investigational treatment for Alzheimer's disease or other dementia within 3 months prior to screening, or received passive immunotherapy (antibody) for the treatment of Alzheimer's disease or other dementia within 6 months prior to screening, or previously received a vaccine for the treatment of Alzheimer's disease or other dementia; or participated in other new drug clinical trials within 30 days prior to enrollment; 11. At present, the researcher suffers from serious diseases, such as infectious diseases, infectious diseases, endocrine or metabolic diseases, as well as serious cardiac function, liver function, lung function, and kidney function damage, and believes that participation in this study will have adverse effects on the subject or the research results 12. Currently suffering from a disease or factor that causes QT interval prolongation, including torsades de pointes, QT prolongation syndrome, hyperkalemia, hypocalcemia, or taking medications that can prolong the QT interval, such as quinidine, amiodarone, or sotalol 13. There are other situations that researchers consider unsuitable for participating in the experiment.
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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
2 sites. 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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Huashan Hospital of Fudan University
RECRUITINGShanghai, Province, 201199, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China