Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Caregiver reported treatment compliance |
Caregivers will document treatment sessions in a logbook to monitor compliance. |
12 weeks |
|
Primary |
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly. |
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired. |
Baseline to Week 12 |
|
Secondary |
Device safety according to the number of device-related adverse events |
Subjects will be monitored for clinical evidence of device-related adverse events throughout the study. |
Baseline to Week 12 |
|
Secondary |
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly. |
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired. |
Baseline to Week 3 |
|
Secondary |
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly. |
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired. |
Baseline to Week 6 |
|
Secondary |
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score |
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence. |
Baseline to Week 3 |
|
Secondary |
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score |
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence. |
Baseline to Week 6 |
|
Secondary |
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score |
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence. |
Baseline to Week 12 |
|
Secondary |
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview. |
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). |
Baseline to Week 3 |
|
Secondary |
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview. |
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). |
Baseline to Week 6 |
|
Secondary |
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview. |
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). |
Baseline to Week 12 |
|
Secondary |
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score. |
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change. |
Baseline to Week 3 |
|
Secondary |
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score. |
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change. |
Baseline to Week 6 |
|
Secondary |
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score. |
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change. |
Baseline to Week 12 |
|
Secondary |
Change in the Electroencephalogram's (EEG) overall power spectral density |
The EEG recordings will give insight into the effect on the neural activity of the brain of the Neuro RX Gamma synchronized and Neuro RX Gamma asynchronized compared to sham. |
Baseline to Week 12 |
|