Alzheimer's Disease Trial, Recruiting NCT06584357 Sponsor: GAP Innovations, PBC Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Recruiting

NCT06584357
Recruiting Not Applicable

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 who are between 60 and 90 years old (inclusive) at the time of signing consent
  • People who have a study partner (such as a family member or close friend) who spends at least 8 hours per week with them and can reliably report on their thinking and daily functioning
  • People who are willing to have a brain MRI within 90 days and amyloid and tau PET brain scans within 120 days of signing consent
  • People who are willing to take part in all study procedures, including blood tests, genetic testing, and storage of biological samples for future research
  • People who are fluent in the language used for testing at the study site
  • People who are willing to be contacted about possible future clinical research trials after this study ends
  • People whose score on a standard memory and thinking test (called the MMSE) falls between 16 and 30 at the screening visit

Who may not be able to join:

  • People who are unable to have amyloid and tau PET scans due to pregnancy, sensitivity to the substances used in the scans, poor vein access, or because the radiation exposure would exceed recommended safety limits
  • People who have had a negative amyloid PET scan result in the past 6 months
  • People who have a medical reason that prevents them from having a brain MRI
  • People who have had a stroke or seizures within the past year
  • People who have had cancer in the past 5 years, with the exception of certain skin cancers or early-stage prostate cancer
  • People who have had a problem with alcohol or drug misuse within the past year
  • People who currently have unstable mental health symptoms (such as uncontrolled depression) that could affect their ability to take part or affect the study results
  • People who have received any treatment aimed at modifying Alzheimer's disease in the past 6 months
  • People who are HIV positive and not on antiviral medication to manage it
  • People who, in the investigator's opinion, have serious or unstable health conditions that would prevent them from completing all study procedures
  • People who have serious or unstable health conditions that would likely prevent them from taking part in an interventional research trial
  • People with untreated conditions such as vitamin B12 deficiency, folate deficiency, or bladder infections that the investigator believes could be affecting their thinking and memory
  • People who have completed cognitive (thinking and memory) testing within 1 month before the screening visit, where the investigator believes prior exposure to the tests could affect results
  • People who have a neurological condition other than Alzheimer's disease affecting the brain or nervous system that may be contributing to memory or thinking problems (such as Parkinson's disease or a history of multiple concussions)
  • People whose score on a depression screening questionnaire (called the GDS) is 8 or above and who the investigator considers to be significantly depressed
  • People whose score on a memory test (called the RAVLT) falls above a certain threshold, calculated using age, sex, education, and racial background as reference points (confirm with trial site)
  • People who weigh less than 110 pounds (approximately 50 kg)
  • People who are direct employees or immediate family members of employees at the participating study sites
  • People who are direct employees of the organisation sponsoring the trial
  • People who, in the investigator's opinion, are unable to complete cognitive testing due to significant vision or hearing difficulties
  • For people taking part in the optional retinal scan component: people with a known allergy or medical reason to avoid the eye drop Tropicamide 1%, which is used to dilate the pupils

For the optional long-term follow-up part of the study, additional criteria apply, including completing the main study, being willing to attend phone check-ins every three months and annual clinic visits, and being willing to have annual PET scans. People who are enrolled or planning to enrol in another Alzheimer's disease trial involving a disease-modifying treatment, or who intend to use such treatments outside of an approved clinical research study, would not be eligible for the follow-up phase.

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 7 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: biohermes-002@globalalzplatfor

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
GAP Innovations, PBC
Registry
ClinicalTrials.gov
Start date
26 September 2024
Est. completion
1 July 2028

Where this trial is recruiting

🇨🇦 Canada 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Biomarkers and PET

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: 7 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