Trial Outcomes & Findings for tACS for Amyloid-β Reduction in Alzheimer's Disease (NCT NCT03290326)
NCT ID: NCT03290326
Last Updated: 2022-08-22
Results Overview
Changes in the amyloid load observed via PET imaging will be evaluated by comparing PET data acquired before and after the 10 tACS sessions. The metric used is SUVR, a measure of the amount of proteins in the brain identified at the PET exam. We will calculate the difference between pre and post tACS SUVR (dSUVR) for the entire brain and report the average value (and standard deviation) for the entire group of patients. A negative value express a decrease in the amount of proteins in the brain post tACS intervention. It must be considered that dSUVR values refer to the entire brain, however patients were treated according to personalized tACS montages targeting patient-specific regions mostly affected by the pathology. This might have led to slightly different changes in SUVR in different part of the brain across participants. Also, as per standard procedures, results are presented at group level, i.e. without considering individual differences in longitudinal amyloid load changes.
COMPLETED
NA
17 participants
Up to six weeks
2022-08-22
Participant Flow
Of 17 enrolled participants, 10 met inclusion criteria and underwent transcranial alternating current stimulation (tACS)
During the screening and baseline procedures 7 participants screened out for the following reasons: 4 participants screened out on cognitive testing measures, being either too advanced or too mild, 2 participants did not meet 6 weeks stable medication inclusion criteria, and 1 participant screened out due to incidental findings on the baseline MRI
Participant milestones
| Measure |
tACS
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) was applied for 1 hour in 10 sessions on consecutive weekdays.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
tACS for Amyloid-β Reduction in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
tACS
n=10 Participants
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) was applied for 1 hour in 10 sessions on consecutive weekdays.
|
|---|---|
|
Age, Customized
Age · 55
|
1 Participants
n=99 Participants
|
|
Age, Customized
Age · 57
|
1 Participants
n=99 Participants
|
|
Age, Customized
Age · 63
|
1 Participants
n=99 Participants
|
|
Age, Customized
Age · 75
|
1 Participants
n=99 Participants
|
|
Age, Customized
Age · 76
|
2 Participants
n=99 Participants
|
|
Age, Customized
Age · 78
|
2 Participants
n=99 Participants
|
|
Age, Customized
Age · 79
|
1 Participants
n=99 Participants
|
|
Age, Customized
Age · 83
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to six weeksPopulation: Mild to Moderate Alzheimer's Disease patients
Changes in the amyloid load observed via PET imaging will be evaluated by comparing PET data acquired before and after the 10 tACS sessions. The metric used is SUVR, a measure of the amount of proteins in the brain identified at the PET exam. We will calculate the difference between pre and post tACS SUVR (dSUVR) for the entire brain and report the average value (and standard deviation) for the entire group of patients. A negative value express a decrease in the amount of proteins in the brain post tACS intervention. It must be considered that dSUVR values refer to the entire brain, however patients were treated according to personalized tACS montages targeting patient-specific regions mostly affected by the pathology. This might have led to slightly different changes in SUVR in different part of the brain across participants. Also, as per standard procedures, results are presented at group level, i.e. without considering individual differences in longitudinal amyloid load changes.
Outcome measures
| Measure |
tACS
n=10 Participants
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays. The tACS intervention (10 sessions) will be preceded and followed by amyloid PET imaging as well as a clinical/cognitive evaluation. The assessment of adverse effects will constitute a Primary outcome measure. Changes in amyloid load in the stimulated brain region will be evaluated and constitute a secondary outcome of the study. Clinically relevant changes in cognitive and clinical scores will be also evaluated as secondary outcomes. Stimulation will be also preceded and followed by electroencephalography (EEG) recording aimed at assessing changes in spectral power in the gamma band.
tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
|
|---|---|
|
Change in Amyloid Burden
|
-1.55 dSUVR
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to six weeksPopulation: The assessment of the effect of 40 Hz tACS on EEG gamma-band spectral power.
EEG power spectral densities (PSD) before and after the tACS intervention were evaluated, specifically absolute and relative power density values (μV2/Hz) were calculated within the gamma band (35-45Hz). Changes in the spectral power are reported in term of percentage of changes in relative spectral power from Pre to Post tACS intervention.
Outcome measures
| Measure |
tACS
n=10 Participants
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays. The tACS intervention (10 sessions) will be preceded and followed by amyloid PET imaging as well as a clinical/cognitive evaluation. The assessment of adverse effects will constitute a Primary outcome measure. Changes in amyloid load in the stimulated brain region will be evaluated and constitute a secondary outcome of the study. Clinically relevant changes in cognitive and clinical scores will be also evaluated as secondary outcomes. Stimulation will be also preceded and followed by electroencephalography (EEG) recording aimed at assessing changes in spectral power in the gamma band.
tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
|
|---|---|
|
Change in EEG Gamma-band Spectral Power
|
23.5 % difference in spectral power (μV2/Hz)
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Up to six weeksChange in Adas-Cog score will be reported, to document a potential clinical benefit of tACS. The scale ranges from a total score of 0-70 with higher score indicating greater cognitive impairment.
Outcome measures
| Measure |
tACS
n=10 Participants
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays. The tACS intervention (10 sessions) will be preceded and followed by amyloid PET imaging as well as a clinical/cognitive evaluation. The assessment of adverse effects will constitute a Primary outcome measure. Changes in amyloid load in the stimulated brain region will be evaluated and constitute a secondary outcome of the study. Clinically relevant changes in cognitive and clinical scores will be also evaluated as secondary outcomes. Stimulation will be also preceded and followed by electroencephalography (EEG) recording aimed at assessing changes in spectral power in the gamma band.
tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
|
|---|---|
|
Change in Adas-Cog Score
|
-0.97 Scores on a scale
Standard Deviation 3.88
|
Adverse Events
tACS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tACS
n=10 participants at risk
Transcranial alternating current stimulation (tACS) tuned at the frequency of 40Hz (gamma frequency) will be applied for 1 hour in 10 sessions on consecutive weekdays.
|
|---|---|
|
General disorders
Headache
|
20.0%
2/10 • 5 months
|
|
General disorders
Scalp Pain
|
20.0%
2/10 • 5 months
|
|
General disorders
Neck Pain
|
20.0%
2/10 • 5 months
|
|
General disorders
Skin Irritation
|
50.0%
5/10 • 5 months
|
|
General disorders
Sensations under electrodes
|
80.0%
8/10 • 5 months
|
|
General disorders
Visual Changes
|
60.0%
6/10 • 5 months
|
|
General disorders
Nervousness
|
30.0%
3/10 • 5 months
|
|
General disorders
Difficulty concentrating
|
20.0%
2/10 • 5 months
|
|
General disorders
Hand tingling
|
10.0%
1/10 • 5 months
|
|
General disorders
Eye pain
|
10.0%
1/10 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place