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NCT04075435 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Anxiety and Alzheimer Disease, sponsored by Mclean Hospital.

Recruiting
Registry status
Early Phase 1
Development phase
12
Enrollment target
1
Study location

NCT04075435 is a Early Phase 1 study of Anxiety and Alzheimer Disease that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 12 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04075435, a Early Phase 1 study of Anxiety and Alzheimer Disease, is actively recruiting participants, sponsored by Mclean Hospital.

RECRUITING
Registry status
Early Phase 1
Development phase
12 participants
Enrollment target
1
Study location

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).

Interventions

  • DRUG high CBD/low THC sublingual solution

Study Locations (1)

Massachusetts

  • McLean Hospital - Belmont

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2021-01-11
Est. Completion 2026-01-16
Phase Early Phase 1

Sponsor

Mclean Hospital

140 total trials

What the Registry Record Tells You About NCT04075435

The ClinicalTrials.gov registry entry for NCT04075435 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower). The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which high CBD/low THC sublingual solution is the first listed.

NCT04075435 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04075435 about?

NCT04075435 is a clinical study titled "Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia". 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).

What is the current status of trial NCT04075435?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-01-11. Estimated completion is 2026-01-16.

What conditions does trial NCT04075435 study?

This clinical trial studies the following conditions: Anxiety, Alzheimer Disease, Agitation,Psychomotor, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease.

What interventions are being tested in trial NCT04075435?

The interventions under investigation include: high CBD/low THC sublingual solution (DRUG).

Who is sponsoring clinical trial NCT04075435?

This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04075435 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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