Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD and TBI

This is an interventional supportive care trial for Dementia Read More

50 participants with possible or probable Alzheimer's disease dementia (of all severity stages) as defined by the NIA-Alzheimer's Association 2011 criteria will be enrolled, along with a family (i.e., unpaid) caregiver. A second cohort of 25 participants who have sustained moderate to severe TBI as diagnosed by UAB-TBIMS standards (generally Glasgow Coma Scale score of 12 or less at admission, cranial imaging with evidence of acute intracranial trauma, and/or post-traumatic amnesia duration of greater than 24 hours) ≥6 months prior to study entry (and their caregivers) will be enrolled.

Entry is dependent on caregiver ratings on at least one of three behavioral domains of the Neuropsychiatric Inventory (NPI): 1) Agitation/Aggression, 2) Disinhibition, 3) Irritability /Lability. Based on standard scoring of the NPI, the caregiver must report all of these for at least one domain:

• Frequency of "Often" (several times per week but less than every day) or more,
• Severity of "Moderate" (stressful and upsetting; may require specific management) or higher
• Distress of "Moderate" (fairly distressing, not always easy to cope with) or higher

The caregiver must also report that the adverse behavior is triggered by resistance to care-related activities, e.g., bathing, taking medications, attending health-care appointments, etc.

Additional inclusion criteria.

• Age ranges AD: ≥ 50 years; TBI ≥ 19; Caregiver ≥18
• Sex distribution: both men and women.
• Race: any.
• Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). Vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures, or participants who per clinician criteria are deemed eligible to participate in the study. .
• Cognitive function and spoken/written English language skills sufficient to provide valid results on neuropsychological testing, or participants who per clinician criteria are deemed eligible to participate in the study.
• Concomitant medications: Subjects may be on stable doses of any psycho-active agents for ≥30 days prior to screening and randomization.
• Caregiver: unpaid person who provides support or supervision for at least 1 instrumental activity of daily living for the affected person, with direct contact averaging ≥5 of every 7 days, and ≥21 hours weekly.
• Access to high-speed/broad band internet service through home computer capable of operating "Go-to-Meeting" or equivalent conferencing software.

Exclusion criteria.

• Absence of a reliable caregiver who is willing to participate and comply with protocol responsibilities (described below).
• Evidence of other psychiatric/neurologic disorders sufficient to be the primary source of cognitive impairment (i.e., stroke, idiopathic Parkinson's disease, schizophrenia, bipolar or unipolar depression, seizure disorder).
• Psychotic features (delusions or hallucinations) not adequately treated or not on stable medical therapy for these conditions 30 days prior to enrollment.
• Current or recent (within the past 2 years) history of alcoholism or drug misuse.
• Subject and/or caregivers who are unwilling or unable to fulfill the requirements of the study.
• Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study.