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New treatment option for Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's...
Official title Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function
ClinicalTrials.gov ID: NCT07422857
What this study is testing
What is [18F]-APN-1607?
[18F]-APN-1607 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for subjects with mild cognitive impairment (mci) of ad, alzheimer's disease (ad) dementia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- people must be able to understand and voluntarily sign a written informed consent form (ICF);
- Age ≥ 50 years, regardless of gender;
- people with HV, MCI, and AD should meet the clinical diagnostic criteria
- Can tolerate brain MRI and PET imaging examinations;
- 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...
You likely can't join if
- Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria
- Possible presence of frontotemporal degeneration (FTLD), characterized by progressive psych behavioral abnormalities and executive...
- The core symptoms of Lewy body dementia include fluctuating cognitive changes accompanied by significant attention and arousal abnormalities...
- Currently suffering from significant mental illness. people with accompanying psychiatric symptoms need to be carefully evaluated by the researchers...
- Brain structural abnormalities confirmed by MRI, such as large strokes (infarct area greater than 4 cm) or intracranial space-occupying lesions;
- Suffering from claustrophobia or unable to tolerate imaging procedures for other reasons;
See the full eligibility criteria
- people must be able to understand and voluntarily sign a written informed consent form (ICF);
- Age ≥ 50 years, regardless of gender;
- people with HV, MCI, and AD should meet the clinical diagnostic criteria
- Can tolerate brain MRI and PET imaging examinations;
- 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...
- Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria
- Possible presence of frontotemporal degeneration (FTLD), characterized by progressive psych behavioral abnormalities and executive dysfunction，Characterized primarily by impairment and language function, progressive...
- 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...
- Currently suffering from significant mental illness. people with accompanying psychiatric symptoms need to be carefully evaluated by the researchers to determine whether they can complete the imaging process;
- Brain structural abnormalities confirmed by MRI, such as large strokes (infarct area greater than 4 cm) or intracranial space-occupying lesions;
- Suffering from claustrophobia or unable to tolerate imaging procedures for other reasons;
- History of alcohol or drug abuse/dependency;
- Hypersensitivity to the investigational drug or any of its components;
- Currently pregnant or breastfeeding;
- 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...
- 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...
- 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...
- There are other situations that researchers consider unsuitable for participating in the experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Shanghai, Province, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Shanghai, Province, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.