Start: August 2021
End: August 30, 2024
What Is This Study About?
This study will evaluate whether treatment for insomnia can reduce neuropsychiatric symptoms, such as anxiety, depression, agitation, irritation, and apathy, in adults with or at risk of developing Alzheimer's disease. Participants will be randomly assigned to either cognitive behavioral therapy or desensitization therapy for insomnia for six weeks. All participants will keep a sleep diary and wear a wrist device to track their sleep. Researchers will measure neuropsychiatric symptoms and severity of insomnia at study start, weekly during treatment, and six months after treatment. In addition, the researchers will obtain an MRI brain scan at the start of the study and after six weeks to evaluate emotional responses.
Do I Qualify To Participate in This Study?
- Diagnosis of mild cognitive impairment or mild Alzheimer's disease
- Insomnia associated with daytime impairment or distress
- Reporting sleep disturbance within the past three months
- Neuropsychiatric symptoms (e.g., depression, anxiety, irritability)
- Fluent and able to read and write in English
- Medications, including any dementia-related medications, at a stable dosage for at least four weeks prior to starting the study
- Global Clinical Dementia Rating of 0.5 or 1.0
- No conditions or metal devices that may make getting an MRI unsafe (e.g., epilepsy, claustrophobia, morbid obesity, heart pacemaker)
- Availability of a caregiver or study partner to help facilitate the study procedures
- Able to verbalize understanding of involvement in the research and provide written informed consent or have a legally authorized representative
Must NOT have:
- Mini-Mental State Examination score <20
- Any uncontrolled or unstable illness, including:
- Thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (>3 times per night);
- Severe cardiac illness (e.g., congestive heart failure)
- Cancer if less than one year since the end of treatment
- Severe respiratory diseases (e.g., asthma, emphysema) uncontrolled with medications
- Neurological disorders other than mild Alzheimer's disease (e.g., Parkinson's disease, unstable epilepsy)
- Unstable adult-onset diabetes
- Use of medication prescribed for sleep disturbance and unwilling or unable to discontinue at least one week prior to starting the study
- History of bipolar disorder
- History of psychosis before the onset of memory impairment
- Substance abuse or dependence, including excessive alcohol consumption (>14 drinks per week or >4 drinks per occasion)
- Exposure to trauma within the past three months
- High suicide risk with suicidal ideations
- Mild traumatic brain injury, such as a history of physical brain injury or blow to the head resulting in loss of consciousness for >5 minutes
- Severely limited vision, hearing and/or hand movement that is likely to interfere with study assessments
- Current or expected cognitive behavioral therapy for another condition (e.g., depression)
- Caffeine consumption of more than three, eight-ounce cups before lunch every day for three weeks prior to starting the study
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Andrea Goldstein-Piekarski, PhD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Stanford University
National Institute of Mental Health (NIMH)
Source: ClinicalTrials.gov ID: NCT04100057