Early Phase 1 Alzheimer's Disease Trial, Recruiting
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 have been diagnosed with mild cognitive impairment or early-stage Alzheimer's disease, or who have noticeable memory problems compared to how they used to function, confirmed by a standard memory assessment
- People whose score on the Mini-Mental State Examination (a standard memory and thinking test) is above 18
- People whose score on the Montreal Cognitive Assessment (another standard thinking test) is below 26
- People who are experiencing at least a mild to moderate level of emotional distress or low mood, as measured by a recognised depression screening tool
- People who are taking acetylcholinesterase inhibitor medications (a common type of Alzheimer's medication) at a stable dose for more than 6 weeks may still be considered
- People who are taking certain antidepressants — specifically SSRIs, SNRIs, or bupropion (at no more than 300mg per day) — at a stable dose and type for at least two months before screening may still be considered
- People who have a close friend or family member who is willing and able to provide observations about them during the study
Who may not be able to join:
- People who are 86 years of age or older
- People who are currently taking antipsychotic medications, MAO inhibitor medications, or antidepressants other than SSRIs, SNRIs, or bupropion (confirm with trial site regarding bupropion dose limits)
- People taking certain long-acting opioid pain medications, unless the timing of their doses can be arranged around the study treatment sessions (confirm with trial site)
- People who are unable to agree to avoid certain medications used for erectile dysfunction or pulmonary hypertension (such as sildenafil or tadalafil) within 72 hours of each study treatment session, as these may cause a dangerous drop in blood pressure
- People with certain heart or cardiovascular conditions, including chest pain (angina), significant heart rhythm problems, a mini-stroke in the last 6 months, a history of stroke, artificial heart valves, or blood pressure that is not well controlled
- People with a resting heart rate below 50 beats per minute, unless a heart specialist has specifically cleared them for participation
- People who have a seizure disorder (epilepsy)
- People who have insulin-dependent diabetes
- People with significant kidney disease
- People with notably elevated liver enzyme levels, which may indicate liver problems
- People who have been diagnosed with schizophrenia, a psychotic disorder (not caused by substances or a medical condition), or Bipolar I Disorder
- People who have a parent or sibling with a diagnosis of schizophrenia, a psychotic disorder (not caused by substances or a medical condition), or Bipolar I Disorder
- People who have used hallucinogenic substances in the past year
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.
Contact this trial
Principal Investigator: Albert Garcia-Romeu, PhD, Johns Hopkins University
Phone: 4105505466
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
Where this trial is recruiting
Primary endpoints
Change in Cornell Scale for Depression in Dementia (CSDD) score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.