Dementia
Conditions
Keywords
dementia alzheimers frontotemporal lyme,, lewy body cognitive impairment
Brief summary
This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.
Detailed description
What hypotheses are you testing? We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures. Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.
Interventions
DEVICE1072nm infrared Photobiomodulation
1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
DEVICEPhotobiomodulation SIMULATED
Device mounted and procedure followed but with no stimulation.
Sponsors
Maculume Ltd.
Quietmind Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Small placebo controlled randomized trial.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 50 - 85 years. * Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30). * Generally healthy otherwise as indicated by recent physical examination. * Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient. * If taking any psychotropic medication should have been stable for the previous 3 months. * Must have had B12, folic acid, full blood count and ferritin screen within the previous 6 months or be on B12 and/or folic acid replacement.
Exclusion criteria
* Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD). * Diagnosed actively growing intracranial pathology (tumors etc). * An associated psychotic illness. * Misusing illegal substances or alcohol. * On regular systemic steroids or anti-metabolites. * Systemic malignancies and/or space occupying lesions in the brain. * Not fluent in English. * Depressed as assessed by Beck Depression Inventory score. * Epilepsy. * Lacking the capacity to give informed consent. * Previous history of stroke or heart attack. * History of aggression or violence. * Inability to travel to the research venue for multiple assessments. * A history of major psychiatric illness, seizure disorder, or physical illness that would compromise their participation in a daily treatment regimen. * A participant may be disqualified if their performance is above the normative mean or below the lowest interpretable score of neuropsychological tests provided during the initial assessment (see #6, Sources of research material obtained from study participants, below).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall. | Post-tx (total intervention period = 28 days) scores to be compared to baseline scores. | Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group received actual tx | 6 |
| Placebo Group received placebo tx | 3 |
| Total | 9 |
Baseline characteristics
| Characteristic | Treatment Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 80 years | 84 years | 81 years |
| Delayed word recall | 0.50 units on a scale | 1.33 units on a scale | 0.798 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
| Trail making A | 0.83 errors at task | 9.00 errors at task | 3.56 errors at task |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 |
| other Total, other adverse events | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
Primary
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.
Time frame: Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall. | 3.17 units on a scale |
| Placebo Group | Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall. | 3 units on a scale |