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Trial Outcomes & Findings for Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia (NCT NCT01059877)

NCT ID: NCT01059877

Last Updated: 2018-09-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.

Results posted on

2018-09-27

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment Group
received actual tx
Placebo Group
received placebo tx
Overall Study
STARTED
6
5
Overall Study
COMPLETED
6
3
Overall Study
NOT COMPLETED
0
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment Group
n=6 Participants
received actual tx
Placebo Group
n=3 Participants
received placebo tx
Total
n=9 Participants
Total of all reporting groups
Age, Continuous
80 years
n=6 Participants
84 years
n=3 Participants
81 years
n=9 Participants
Sex: Female, Male
Female
2 Participants
n=6 Participants
2 Participants
n=3 Participants
4 Participants
n=9 Participants
Sex: Female, Male
Male
4 Participants
n=6 Participants
1 Participants
n=3 Participants
5 Participants
n=9 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
6 Participants
n=6 Participants
3 Participants
n=3 Participants
9 Participants
n=9 Participants
Delayed word recall
0.50 units on a scale
n=6 Participants
1.33 units on a scale
n=3 Participants
0.798 units on a scale
n=9 Participants
Trail making A
0.83 errors at task
n=6 Participants
9.00 errors at task
n=3 Participants
3.56 errors at task
n=9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Treatment Group
n=6 Participants
received actual tx
Placebo Group
n=3 Participants
received placebo tx
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
3.17 units on a scale
Interval 2.0 to 4.0
3 units on a scale
Interval 3.0 to 3.0

Adverse Events

Treatment Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marvin Berman, PhD

QuietMind Foundation

Phone: 610.940.0488

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place