Cannabidiol: Treatment for brain changes and depression in early-stage dementia

Phase 2

• Conditions: Early-stage dementia; Neurological - Dementias

• Registration Number: ACTRN12621001364864
• Lead Sponsor: niversity of Wollongong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-08
• Study Completion: 2022-11-17
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1.Community-dwelling individuals who can provide written informed consent, with a clinician confirmed primary diagnosis of early dementia made within the past 24 months. Participants must have a nominated supporting person, preferably living with them (e.g. spouse) who can assist with daily medication monitoring.
2.A Stage 3-5 rating on the Global Deterioration Scale (GDS)
3.A score of 20-26 on the Mini Mental State Exam (MMSE);
4.If taking general medications (e.g. Micardis, Advil), participants must have been taking them for a minimum of 6-12 weeks prior to the start of the trial, with no changes to medication regime during the 12-week trial period unless clinician-recommended changes are required for appropriate care.

Exclusion Criteria

Participants will be excluded on the basis of:
1.MRI contraindications, such as severe head injury, pace devices, coronary or peripheral artery stents, cochlear implants, renal insufficiency or claustrophobia;
2.Allergies to the excipient used in the formulation of the capsules;
3.Impaired liver or kidney or heart function;
4.Active suicidal ideation;
5.Intake of CBD, THC or cannabis within one month prior to participation;
6.Prior extensive use of CBD, defined as use greater than weekly for more than 3 months in the two years prior to participation;
7.A clinically relevant history of recreational cannabis use or other drugs of abuse, defined as more than three times a week for any continuous period of longer than 6 months in duration in the year prior to participation;
8.Prior history of treatment for alcohol use disorder in the year prior to participation, or a current score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT);
9.Any current or recent diagnoses of neurological disorders other than dementia, including epilepsy or Parkinson’s disease;
10.Current use of medications that have clinically relevant interactions with the cytochrome P450 (CYP) 2C19 or CYP3A classes of liver enzymes prior to study inclusion (e.g. antipsychotics, antidepressants, anxiolytics);
11.Participation in any other clinical drug trials within 30 days of the current study;
12.Anticipated surgical needs within 3 months of participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified