Aging, Alzheimer Disease, CBT, Cognitive Impairment, Sleep
Conditions
Brief summary
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.
Interventions
BEHAVIORALSleep intervention
Behavioral sleep intervention program
BEHAVIORALPlacebo intervention
Quasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration)
Sponsors
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥65 years old * Memory complaints verified by an informant * Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease * General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician * No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease * Adequate visual and auditory acuity to allow neuropsychological testing * Meets International Classification of Sleep Disorders-2nd edition (ICSD-2) criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping
Exclusion criteria
* Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma * Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), such as major depression, bipolar disorder, schizophrenia and other psychotic features * Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol * History of alcohol or substance abuse within the past 2 years * Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Enrolled to the Study | Up to 24 weeks following study initiation |
| Number of Participants That Complete the Study | Through study completion, up to 34 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep as Assessed by Actigraphy | Through study completion, up to 34 weeks | Week-long measurement using wrist actigraphy |
| Cognitive Function Assessed by Standard Neurocognitive Battery | Through study completion, up to 34 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Intervention An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment | 8 |
| Placebo Intervention Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration). | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unexpected closure of study components | 8 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Sleep Intervention | Total | Placebo Intervention |
|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 5.15 | 74.93 years STANDARD_DEVIATION 4.88 | 74.1 years STANDARD_DEVIATION 4.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Insomnia Severity Index (ISI) | 16.8 units on a scale STANDARD_DEVIATION 5.52 | 16.03 units on a scale STANDARD_DEVIATION 5.11 | 15.2 units on a scale STANDARD_DEVIATION 4.9 |
| Pittsburgh Sleep Quality Index (PSQI) | 9.88 units on a scale STANDARD_DEVIATION 3.18 | 10.6 units on a scale STANDARD_DEVIATION 3.31 | 11.4 units on a scale STANDARD_DEVIATION 3.51 |
| Quick Dementia Rating System (QDRS) Category Mild cognitive impairment | 4 Participants | 8 Participants | 4 Participants |
| Quick Dementia Rating System (QDRS) Category Mild dementia | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 12 Participants | 5 Participants |
| Region of Enrollment United States | 8 participants | 15 participants | 7 participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 0 Participants |
| STOP-BANG sleep apnea scale High risk | 1 Participants | 1 Participants | 0 Participants |
| STOP-BANG sleep apnea scale Intermediate risk | 5 Participants | 6 Participants | 1 Participants |
| STOP-BANG sleep apnea scale Low risk | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Participants Enrolled to the Study
Time frame: Up to 24 weeks following study initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sleep Intervention | Number of Participants Enrolled to the Study | 8 Participants |
| Placebo Intervention | Number of Participants Enrolled to the Study | 7 Participants |
Primary
Number of Participants That Complete the Study
Time frame: Through study completion, up to 34 weeks
Population: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Secondary
Cognitive Function Assessed by Standard Neurocognitive Battery
Time frame: Through study completion, up to 34 weeks
Population: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Secondary
Sleep as Assessed by Actigraphy
Week-long measurement using wrist actigraphy
Time frame: Through study completion, up to 34 weeks
Population: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.