Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer s Disease

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Aging (NIA)
Study ID
NCT07721467
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    25 mg orally x 2 (2 weeks apart)
  • Cognitive Training — OTHER
    daily for 4 weeks

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: early-stage Alzheimer's Disease (AD) population - cognitive training only
    older adults with early-stage AD, 4 weeks of cognitive training alone
  • Experimental: early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybin
    older adults with early-stage AD, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks
  • Active Comparator: Normal Cognition population - cognitive training only
    Older adults with normal cognition, 4 weeks of cognitive training alone
  • Experimental: Normal Cognition population - cognitive training plus psilocybin
    Older adults with normal cognition, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks

Primary Outcome Measure

Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS)) [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute of Aging, Clinical Research UnitBaltimoreMaryland21224
Dimitrios Kapogiannis, M.D.
[email protected]
667-391-0063

Find similar trials in Baltimore, MD

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By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
National Institute of Aging, Clinical Research Unit· Baltimore, MD

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