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Alzheimer's Disease / Cognitive Training / Psilocybin · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 clinical trial registration (not yet recruiting) designed to test whether psilocybin enhances neuroplasticity gains from cognitive training in older adults with mild cognitive impairment or early Alzheimer's disease. No results are reported in this registry record; the study measures a neuroplasticity composite score at 4 weeks as the primary outcome. This represents early-stage investigation of a novel combination therapy and cannot yet inform clinical practice.
Phase 2, Interventional, Randomized, Parallel, Open label, Other purpose. Alzheimer's Disease; age from 65 Years; to 120 Years; accepts healthy volunteers. Intervention: early-stage Alzheimer's Disease (AD) population - cognitive…; Normal Cognition population - cognitive training plus psilo…. Compared with: early-stage Alzheimer's Disease (AD) population - cognitive… — Active Comparator; Normal Cognition population - cognitive training only — Active Comparator. n = 200. 1 site: United States.
This is a Phase 2 clinical trial registration (not yet recruiting) designed to test whether psilocybin enhances neuroplasticity gains from cognitive training in older adults with mild cognitive impairment or early Alzheimer's disease. No results are reported in this registry record; the study measures a neuroplasticity composite score at 4 weeks as the primary outcome. This represents early-stage investigation of a novel combination therapy and cannot yet inform clinical practice.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
No clinical impact can be determined from a registry record with no results posted. Clinicians should monitor for publication of results once the trial is complete and peer reviewed.
This is a Phase 2 interventional study registration with no reported results; it describes a planned trial of psilocybin combined with cognitive training in older adults with cognitive impairment, currently in pre-recruitment status.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be determined from a registry record with no results posted. Clinicians should monitor for publication of results once the trial is complete and peer reviewed.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07721467). This is a study registration, not published results. Lead sponsor: National Institute on Aging (NIA). Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DRUG: Psilocybin; OTHER: Cognitive Training. Primary outcome measures: Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS)) , 4 weeks. Brief summary: Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function. Objective: To learn how regular cognitive training, with or without psilocybin, can improve brain health in older adults. Eligibility: People aged 65 years and older with mild cognitive impairment or early-stage Alzheimer s disease. Healthy older adults with normal cognition are also needed. Design: Participants will be screened. They will have a test of their heart function and an imaging scan. They will have mental health screening and tests of their thinking and memory. They will practice brain-training tasks on a tablet. Participants will be divided into 2 groups: 1 will have cognitive training plus psilocybin; 1 will have cognitive training only. Those having cognitive training only will have 5 or 6 clinic visits. They will take the tablet home to practice brain training daily. They will wear a device to measure brain waves as they sleep; they may have 1 overnight stay in the clinic, or they may wear the device at home. Imaging scans and other tests will be repeated at each visit. Those taking psilocybin will have up to 9 clinic visits. In addition to the visits for cognitive training, they will take 1 psilocybin capsule by mouth 2 weeks apart (the second dose is optional). They will remain in the clinic for 24 hours after each dose.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.