Trial intelligence / Profile preview

NECTAR: Psilocybin and Cognitive Training in Aging and Alzheimer's Disease

NCT07721467Phase 2

Key facts

Status: Recruiting
Start: Nov 2026
Primary completion: Dec 2030
Countries: 1
Sponsor: National Institute on Aging

Drugs: psilocybin
Conditions: Alzheimer's disease (AD)

Overview

Phase 2, randomised, open-label trial of psilocybin in Alzheimer's disease (AD) (4 arms), sponsored by National Institute on Aging. Primary endpoint: Neuroplasticity Composite Score at 4 weeks. Started Nov 2026; status: recruiting.

Design

4 arms

Study design: RandomizedOpen-label

early-stage Alzheimer's Disease (AD) population - cognitive training only
4 weeks of cognitive training alone
early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybin
Two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks
Normal Cognition population - cognitive training only
4 weeks of cognitive training alone
Normal Cognition population - cognitive training plus psilocybin
Two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks

Who it enrols

Adults aged 65 and older with mild cognitive impairment or early-stage Alzheimer's disease, as well as healthy older adults with normal cognition.

Endpoints

Primary

Neuroplasticity Composite Score4 weeks

Secondary

Incidence of adverse events6 weeks
Neuroplasticity Composite Score4 days
TabCAT Brain Health Assessment4 weeks
Repeatable Battery for the Assessment of Neuropsychological Status4 weeks
Autobiographical Memory Performance4 weeks
MRI, resting state fMRI, and MRS measures4 weeks
Sleep architecture and quantitative EEG spectral power4 weeks
Plasma and plasma EV-associated markers4 weeks

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