Randomised trial aiming to prevent development of depression and improve quality of life in individuals with dementia (Alzheimer’s disease)

Not Applicable

• Conditions: Depression; Alzheimer's disease; Neurological - Alzheimer's disease; Mental Health - Depression

• Registration Number: ACTRN12616000886482
• Lead Sponsor: WA Centre for Health and Ageing

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-06
• Study Completion: 2019-01-03
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

The inclusion criteria will be;
* Diagnosis of major neurocognitive disorder due to probable Alzheimer's disease according to DSM-5 criteria
* Mini-Mental State Examination (MMSE) score of greater than or equal to 15
* Neuropsychiatric Inventory (NPI) depression domain score of 1 (i.e. no depression)
* Availability of a close and reliable informant
* Fluent in written and spoken English

Exclusion Criteria

We will exclude individuals who;
* Have a medical condition that is likely to compromise their ability to complete the required activities of the study (e.g. severe sensory impairment)
* Consume alcohol in excess of 28 standard drinks per week
* Have no health practitioner who can provide ongoing clinical care
* Have a contra-indication to MRI (MRI sub-group only)
* Decline or are unable to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A primary outcome is the incidence of clinically significant depressive symptoms in patients with Alzheimer's disease (AD) across the duration of the trial. <br><br>The Neuropsychiatric Inventory (NPI) will be used to establish the presence of clinically significant depression.[This primary outcome will be assessed at multiple time points across the duration of the trial. These time points are; baseline, 4 weeks, 6 months, 12 months, and 24 months. ];A primary outcome is the severity of clinically significant depressive symptoms in patients with Alzheimer's disease (AD) across the duration of the trial.<br><br>The Cornell Scale for Depression in Dementia (CSDD) will be used to measure severity of depressive symptoms.[This primary outcome will be assessed at multiple time points across the duration of the trial. These time points are; baseline, 4 weeks, 6 months, 12 months, and 24 months. ]