Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Early phase 1: NirsCure with Lecanemab for Alzheimer Disease
The goal of this study is to explore the how well it works and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD). This study will employ a randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled method with an open-label extension phase.
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are NirsCure with Lecanemab, sham NirsCure with Lecanemab, or NirsCure with Lecanemab. The registry lists allocation as randomized. The goal of this study is to explore the how well it works and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD).
They plan to enroll about 20 people at Beijing. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
Primary outcome (registry wording): The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
Who it is for (from inclusion criteria)
Ages 50 Years to 90 Years
Age between 50 and 90 years old, gender unrestricted;
Meet the core clinical diagnostic criteria for probable Alzheimer's disease as defined by the National Institute on Aging and the Alzheimer's Association (2011 NIA-AA);
Amyloid positivity confirmed by Amyloid PET;
Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;
Mini-Mental State Examination (MMSE) score ≥ 15;
Participants must have an educational level of primary school or above and be capable of completing the cognitive assessments and other tests as specified in the protocol;
If taking cognition-enhancing medications, the dosage must have been stable for at least 12 weeks prior to enrollment (psychotropic drug dosage stable for at least 4 weeks);
Who the registry excludes
Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);
APOE genotype of ε4/ε4;
More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;
Currently taking anticoagulant medications;
History of epilepsy or hemorrhagic stroke within the past 12 months;
Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;
Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06992804?
Early phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06992804?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.