Phase 4 Alzheimer's Disease Trial, Recruiting NCT07633470 Sponsor: Alpha Cognition, Inc Condition: Alzheimer's Disease
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Phase 4 Alzheimer's Disease Trial, Recruiting

NCT07633470
Recruiting Phase 4

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 a man or woman aged 50 or older at the time you agree to take part
  • You have been diagnosed with probable Alzheimer's disease, confirmed by a specific blood test that measures certain proteins linked to Alzheimer's (the Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 test)
  • You have mild-to-moderate memory and thinking difficulties, confirmed by a short mental status test at the screening visit, with your qualifying score depending on your level of education
  • You are able to give your own consent to join, or a legally authorised representative or caregiver can do so on your behalf if needed
  • Any regular medications you take have been at a stable dose for at least 4 weeks
  • Any recent medication changes (within 8 weeks) will be reviewed to make sure they won't affect the study results (confirm with trial site)
  • You have a reliable caregiver or close contact who spends at least 20 hours per week with you, can attend all study visits, and can regularly complete questionnaires about your symptoms and wellbeing
  • You have not taken any medications that are not allowed in this study within at least 2 weeks (or longer, depending on the medication) before the study starts
  • You and your caregiver are willing and able to attend all appointments and follow all study procedures as an outpatient

Who may not be able to join:

  • Your dementia is caused by something other than Alzheimer's disease, such as vascular dementia, Lewy body dementia, Parkinson's disease dementia, frontotemporal dementia, Huntington's disease, or dementia caused by substances or medications
  • Your blood test result does not confirm the biological markers associated with Alzheimer's disease
  • You have been admitted to a psychiatric or mental health unit in the past 3 months or are currently in one
  • You have another serious or unstable medical condition that, in the doctor's judgement, could put you at risk or affect the study — this includes certain heart, liver, kidney, lung, blood, hormone, or neurological conditions, recent cancer (within 2 years, with some exceptions), or consistently very high blood pressure or a very low heart rate
  • You currently have an active diagnosis of delirium (sudden confusion), psychosis, or a psychotic disorder
  • You have active major depression that required starting or changing antidepressant treatment within the past 2 months
  • You are currently experiencing diarrhoea, nausea, vomiting, or stomach pain, or have a digestive condition (such as gastric bypass surgery) that could affect how the study drug is absorbed
  • You have a history of seizures, anorexia nervosa, or bulimia
  • You are experiencing sudden acute confusion at the start of the study that has not resolved
  • You have a known allergy or sensitivity to the study drug (Zunveyl®) or any product containing galantamine
  • You have taken another experimental drug or device for brain or psychiatric symptoms within the past 30 days (or longer, depending on the medication)
  • Your life expectancy is less than 12 months, or you are currently receiving hospice or palliative care that would conflict with study participation
  • You have any other medical, neurological, or psychiatric condition that, in the doctor's judgement, could put you at risk or affect the study
  • You are currently taking or have ever previously taken Zunveyl®
  • You have lost more than 10% of your body weight in the 6 months before screening (confirm with trial site)
  • You have any planned surgery scheduled during the study period
  • You have a history of a severe skin reaction called Stevens-Johnson Syndrome
  • Your blood tests show significantly abnormal kidney or liver function
  • You are taking certain medications that strongly affect how the body processes drugs, or medications with a high burden of anticholinergic effects (medicines that block certain nerve signals), and these cannot be stopped — or you would need to start a new psychiatric medication during the study (confirm with trial site)

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 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: (618) 407-6732

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
Phase 4
Sponsor
Alpha Cognition, Inc
Registry
ClinicalTrials.gov
Start date
20 May 2026
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs); Percentage of Participants who Discontinued due to AEs; Number of Participants with Treatment Interruptions or Dose Reductions; Global Tolerability Score

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: 20 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