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NCT05345509

NCT05345509
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are a generally healthy man or woman between 18 and 55 years old.
  • You are a non-smoker or only smoke occasionally (fewer than 10 cigarettes or the nicotine equivalent per week), and you are willing to not smoke while staying at the study site.
  • Your body weight and height fall within a specific healthy range (BMI between 18.0 and 32.0), and you weigh at least 55 kg if male or at least 50 kg if female.
  • If you are a man who is sexually active with a male partner, you must be willing to use a condom throughout the study.
  • If you choose not to have sexual intercourse as your normal lifestyle, you may be eligible under this condition.
  • You are willing to avoid pain relievers such as ibuprofen, naproxen, aspirin, and similar drugs from the start of screening until the end of the study.
  • You are willing and able to sign a consent form agreeing to take part after having the study fully explained to you.

Who may not be able to join:

  • You had any notable health problems found during your physical check-up at screening.
  • Your blood test results showed significant abnormalities, or you tested positive for HIV, hepatitis B, or hepatitis C.
  • You are pregnant, tested positive on a pregnancy test at screening or just before the study starts, or you are currently breastfeeding.
  • You tested positive for drugs or alcohol at screening or just before the study starts.
  • You have a history of any form of cancer or tumour growth.
  • You have had a significant allergic reaction (such as severe drug reactions, anaphylaxis, swelling, or hypersensitivity) to donepezil, dimenhydrinate, benzatropine, related medicines, or any ingredient in the study drugs.
  • You have an inherited condition affecting how your body handles certain sugars, such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (this applies to one part of the study only — confirm with trial site).
  • Your liver enzyme levels or bilirubin (a substance in the blood) are higher than 1.5 times the accepted normal range at screening or just before the study starts.
  • Your kidneys are not filtering blood well enough, based on a specific calculation used to measure kidney function (confirm with trial site).
  • You have abnormal heart rhythm readings on an ECG, or your blood pressure or heart rate falls outside acceptable ranges at screening or just before the study starts.
  • You have a history of a significantly slow heart rate or certain heart rhythm conduction problems (confirm with trial site).
  • You have a history of significant asthma (unless it was a childhood condition that has completely gone away) or chronic obstructive pulmonary disease (COPD).
  • You have had an alcohol problem in the past year, or you regularly drink more than 14 units of alcohol per week in the past 6 months.
  • You have used recreational drugs in the past month (or codeine in the past 3 months), or have had a drug abuse problem in the past year.
  • You have donated plasma in the last 7 days, or donated or lost 500 mL or more of blood in the last 30 days before the study drug is given.
  • You regularly consume high amounts of caffeine — equivalent to more than 3 regular cups of coffee or 2 energy drinks per day.
  • The study doctor believes there is any other reason that would make it unsuitable or unsafe for you to take part.

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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Inventage Lab., Inc.
Registry
clinicaltrials_gov
Start date
1 April 2023
Est. completion
13 November 2025

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

AUClast of IVL3003; AUCinf of IVL3003; AUClast of Aricept; AUCinf of Aricept

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov