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NCT04075435

NCT04075435
Active, Not Recruiting Early Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with probable Alzheimer's disease or mild cognitive impairment (MCI)
  • You scored between 15 and 30 (inclusive) on a standard memory and thinking test called the MMSE
  • You have a clinically significant level of anxiety, based on a specific rating scale used by the study team
  • You have someone available (such as a family member or legal representative) who can sign consent forms on your behalf if needed
  • You have a caregiver who spends at least 10 hours per week with you and is able to attend all study appointments
  • Both you and your study partner (caregiver) must be fluent in English
  • You are between 55 and 90 years old (inclusive)

Who may not be able to join:

  • You have a serious or unstable illness affecting the heart, liver, kidneys, lungs, hormones, nervous system, or blood that could interfere with the study
  • You have a seizure disorder (such as epilepsy)
  • You have ever been diagnosed with bipolar disorder, schizophrenia, or schizoaffective disorder
  • You are currently experiencing a major depressive episode
  • You have had a problem with alcohol or drug misuse or dependence in the past 6 months
  • You are currently experiencing delirium (sudden severe confusion), as measured by the study team
  • You are currently admitted to a hospital
  • You currently use cannabis or cannabinoid products more than once a month
  • You test positive for THC (the active substance in cannabis) in a urine test at the screening or first study visit
  • You have an allergy to coconut
  • You are currently taking certain medications that strongly affect how the body processes drugs, including some antifungals, antidepressants, antibiotics, herbal supplements (such as St. John's Wort), or anti-epileptic drugs (confirm with trial site for the full list of affected medications)

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.

Early Phase 1: approximately ~10% 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
Early Phase 1
Sponsor
Mclean Hospital
Registry
clinicaltrials_gov
Start date
11 January 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Total of clinician impression column on anxiety domain of the NPI-C

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