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Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

NCT04075435 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-30

No results posted yet for this study

Summary

This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).

Conditions

  • Alzheimer Disease
  • Anxiety
  • Agitation,Psychomotor
  • Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Interventions

DRUG

high CBD/low THC sublingual solution

Hemp derived solution to be administered sublingually twice daily.

Sponsors & Collaborators

  • Spier Family Foundation

    collaborator UNKNOWN

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Staci Gruber, PhD · Mclean Hospital

  • Ipsit V Vahia, MD · Mclean Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075435 on ClinicalTrials.gov