Early Phase 1 Alzheimer's Disease Trial, Recruiting NCT06992804 Sponsor: Xuanwu Hospital, Beijing Condition: Alzheimer's Disease
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Early Phase 1 Alzheimer's Disease Trial, Recruiting

NCT06992804
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 50 and 90 years old (any gender)
  • You have been diagnosed with probable Alzheimer's disease based on recognised medical guidelines
  • A special brain scan (called an Amyloid PET) has confirmed the presence of amyloid (a protein linked to Alzheimer's) in your brain
  • Your dementia has been rated as "moderate" on a standard scale called the Clinical Dementia Rating, with a global score of 1
  • You scored 15 or higher on a common memory and thinking test called the MMSE
  • You completed at least primary school education and are able to take part in thinking and memory tests
  • If you are already taking memory or mood medications, your dose has been stable for at least 12 weeks (or at least 4 weeks for mood-related medications)
  • You (or your legal guardian) are willing to take part and sign a consent form
  • You have a caregiver who is available daily (at least 1 hour per day), can read, will help with study tasks and questionnaires, is willing to help you use a near-infrared light therapy device, and agrees to and understands the study procedures

Who may not be able to join:

  • Your memory or thinking problems are caused by something other than Alzheimer's disease, or you have a serious mental health condition such as schizophrenia, bipolar disorder, or severe depression
  • You carry a specific gene variation known as APOE ε4/ε4 (confirm with trial site)
  • A recent brain MRI (within the last 3 months) showed more than 5 small bleeds in the outer part of your brain
  • You are currently taking blood-thinning (anticoagulant) medications
  • You have had epilepsy or a bleeding stroke in the past 12 months
  • You have an allergy or strong sensitivity to sunlight or visible light, or your head or neck skin is particularly sensitive
  • You have had a serious head injury or have metal devices implanted in your head (such as bone screws or plates)
  • You have been diagnosed with a malignant (cancerous) tumour
  • You have an unstable or poorly controlled serious health condition, such as severe heart, lung, digestive, or kidney disease
  • You are unable to have a PET or MRI scan — for example, due to claustrophobia, a pacemaker, or metal implants in your body
  • You are currently receiving a treatment that targets amyloid in the brain and have experienced serious side effects such as brain bleeding or brain swelling
  • You have a current problem with alcohol or drug misuse
  • You are pregnant, breastfeeding, or planning to become pregnant
  • You have taken part in another clinical trial within the past month
  • Your doctor decides there is another reason you should not take part
  • Your caregiver has a serious neurological or psychiatric condition

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Yi Tang, MD, PhD, Xuanwu Hospital, Beijing

Phone: 00861083199456

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Xuanwu Hospital, Beijing
Registry
ClinicalTrials.gov
Start date
28 May 2025
Est. completion
15 October 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov