Early Phase 1 Alzheimer's Disease Trial, Recruiting NCT07323927 Sponsor: Xuanwu Hospital, Beijing Condition: Alzheimer's Disease
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Early Phase 1 Alzheimer's Disease Trial, Recruiting

NCT07323927
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:

  • People aged between 50 and 90 years old at the time of joining, of any gender
  • People who have been diagnosed with probable Alzheimer's disease based on recognised international diagnostic guidelines
  • People whose Alzheimer's disease falls within a moderate range, as measured by standard dementia rating scales used by doctors
  • People who have had brain imaging or spinal fluid tests showing results consistent with Alzheimer's disease
  • People who score between 12 and 26 on a standard memory and thinking test called the MMSE
  • People who are able to read and write, or who have completed at least 4 to 6 years of formal schooling
  • People who, if taking medications for mood, behaviour, or memory, have been on a stable dose of those medications for at least 3 months before joining, with no changes planned during the study; other non-Alzheimer's medications must have been stable for at least 4 weeks before the start of the study
  • People who have a trusted family member, carer, or legal guardian who is able to spend at least 8 hours per week with them throughout the study
  • People who are willing to take part, keep their current treatments unchanged during the study, and who have signed a consent form agreeing to participate

Who may not be able to join:

  • People experiencing psychiatric or behavioural symptoms that are not typically associated with Alzheimer's disease
  • People who have had a mini-stroke, stroke, or seizure within the past 12 months
  • People with a known allergy to the study drug (gantenerumab) or its ingredients, or who have had a severe allergic reaction to similar types of medicines called monoclonal antibodies
  • People with serious heart conditions such as severe irregular heartbeat, poorly controlled high blood pressure (above certain levels), or active stomach or bowel conditions such as peptic ulcers or inflammatory bowel disease
  • People who are unable to have an MRI scan, for example because they have a pacemaker, defibrillator, or certain metal implants in their body
  • People whose MRI scan shows brain changes that suggest a type of dementia other than Alzheimer's disease
  • People whose MRI scan shows certain significant brain abnormalities, such as large areas of bleeding, swelling, damage, abnormal blood vessels, infection, major stroke damage, significant white matter disease, or brain tumours (confirm with trial site regarding any small cysts or benign growths)
  • People who are currently taking part in another clinical trial aimed at treating or improving Alzheimer's disease
  • People with any other unstable or poorly managed health condition that the study doctors believe could affect their safety or the reliability of study results
  • People excluded for any other reason determined by the study doctors

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 23 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, M.D., Ph.D.

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
1 August 2025
Est. completion
1 January 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

CGRP Levels in Cerebrospinal Fluid and Plasma

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: 23 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