Mode
Text Size
Log in / Sign up
N/A Completed N=11 Randomized Triple-blind Treatment

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

Back to search