N/A
Completed N=11
Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
Source: ClinicalTrials.gov NCT01059877 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall. — 3.17; 3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall. |
3.17; 3 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01059877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.