Phase 2 Alzheimer's Disease Trial, Recruiting NCT04436081 Sponsor: Eastern Virginia Medical School Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT04436081
Recruiting Phase 2

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 51 or older
  • People who have been diagnosed with Alzheimer's disease dementia, or a mixed dementia that includes Alzheimer's disease
  • People whose score on a standard memory and thinking test (called the MMSE) falls between 4 and 28
  • People who show signs of agitation or aggression, as measured above a certain level on a standard behavioural rating tool (called the NPI)
  • People, and their caregivers, who can read, write, and speak English well enough to give informed consent
  • People taking memory medications (such as cholinesterase inhibitors or memantine) whose dose has been stable for at least 30 days — or, if those medications were recently stopped, at least 15 days must have passed
  • People whose caregiver either lives with them or spends at least 4 hours per day with them

Who may not be able to join:

  • People with a dementia diagnosis that is not Alzheimer's disease or mixed Alzheimer's disease
  • People whose MMSE score is higher than 28 or lower than 4, indicating either very mild or very advanced dementia
  • People whose agitation or aggression score on the NPI rating tool does not meet the required threshold
  • People with a serious or unstable physical health condition affecting the heart, liver, kidneys, lungs, hormones, nervous system, or blood, which could affect the safety assessment (as determined by the study doctor)
  • People with a current or past diagnosis of certain other psychiatric or neurological conditions, such as psychotic disorders, bipolar disorder, or schizophrenia
  • People who currently misuse or are dependent on marijuana, alcohol, or other drugs
  • People who have a seizure disorder
  • People who are pregnant or breastfeeding
  • People who show signs of delirium at the start of the trial, as assessed using a standard tool called the Confusion Assessment Method
  • People currently taking lithium
  • People who are unable to swallow softgel capsules
  • People whose antidepressant dose has changed within 4 weeks before the trial begins or during the study
  • People whose antipsychotic or benzodiazepine dose has changed within 1 week before the trial begins or during the study
  • People with a known allergy or sensitivity to cannabinoids, as CBD oil is used in this trial
  • People who fall frequently due to a drop in blood pressure when standing (orthostatic hypotension)
  • People currently taking certain medications, including tricyclic antidepressants, fluoxetine, or carbamazepine
  • People who live in a nursing home

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
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Hamid Okhravi, MD, Eastern Virginia Medical School

Phone: 757.446.5675

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 2
Sponsor
Eastern Virginia Medical School
Registry
ClinicalTrials.gov
Start date
26 February 2021
Est. completion
1 March 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in agitation and aggression.; Change in caregiver burden.; Change in the participant's quality of life.; Change in caregiver's quality of life.

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