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Trial Outcomes & Findings for Seizure Activity in Alzheimer's Disease (NCT NCT01554683)

NCT ID: NCT01554683

Last Updated: 2020-07-23

Results Overview

Number of participants who had evaluable fMRI scans with arterial spin labeling to measure brain perfusion blood flow changes in specific brain regions, including the hippocampus

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

3 MRIs acquired at visit 2,3 and 4 between weeks 1 and 6

Results posted on

2020-07-23

Participant Flow

While 12 participants were consented, 3 withdrew prior to receiving medications. 2 were due to claustrophobia preventing MRI and one was due to inability to recall why they were doing the study (so study was discontinued prior to drug administration).

Participant milestones

Participant milestones
Measure
High Dose Levetiracetam, Low Dose, Placebo
levetiracetam given at a dose of 7.5mg/kg over 20 minutes followed by LEV at a dose of 2.5mg/kg over 20 minutes followed by Placebo over 20 minutes
Low Dose Levetiracetam, High Dose, Placebo
Levetiracetam given at a dose of 2.5mg/kg over 20 minutes followed by LEV at 7.5mg/kg over 20 minutes followed by Placebo
Placebo Administration, High Dose LEV, Low Dose
Saline administration via IV infusion over 20 min followed by LEV at 7.5mg/kg followed by LEV at 2.5 mg/kg
High Dose LEV, Placebo, Low Dose
LEV at 7.5mg/kg followed by Placebo, followed by LEV at 2.5mg/kg
Low Dose LEV, Placebo, High Dose LEV
Low dose LEV at 2.5mg/kg followed by placebo followed by High Dose LEV at 7.5mg/kg
Placebo, Low Dose LEV, High Dose LEV
Placebo, followed by low dose LEV at 2.5mg/kg followed by High dose LEV at 7.5mg/kg
Overall Study
STARTED
2
1
3
2
1
0
Overall Study
COMPLETED
2
1
3
2
1
0
Overall Study
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seizure Activity in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=9 Participants
Saline administration via IV infusion over 20 min, High dose LEV 7.5mg/kg, and Low dose LEV at 2.5mg/kg in random order
Age, Continuous
72 years
STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
9 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 MRIs acquired at visit 2,3 and 4 between weeks 1 and 6

Number of participants who had evaluable fMRI scans with arterial spin labeling to measure brain perfusion blood flow changes in specific brain regions, including the hippocampus

Outcome measures

Outcome measures
Measure
High Dose Levetiracetam
n=9 Participants
levetiracetam given at a dose of 7.5mg/kg over 20 minutes
Low Dose Levetiracetam
n=9 Participants
Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
Placebo Administration
n=9 Participants
Saline administration via IV infusion over 20 min
Number of Participants With Evaluable fMRI Scans
temporal lobe perfusion
9 participants
9 participants
9 participants
Number of Participants With Evaluable fMRI Scans
Frontal lobe perfusion
9 participants
9 participants
9 participants

SECONDARY outcome

Timeframe: At visits 2,3,4 in weeks 1-6 (one visit per intervention, visits spaced 2 weeks apart)

Evaluate memory changes, the free and cued selective reminding test lists the number of items recalled from a possibility of 16, adding free recall at two time points, yielding a score on a 0-32 scale per participant. A higher score is better, representing better recall.

Outcome measures

Outcome measures
Measure
High Dose Levetiracetam
n=9 Participants
levetiracetam given at a dose of 7.5mg/kg over 20 minutes
Low Dose Levetiracetam
n=9 Participants
Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
Placebo Administration
n=9 Participants
Saline administration via IV infusion over 20 min
Free and Cued Selective Reminding Test
13.4 score on a scale
Standard Deviation 10
14.3 score on a scale
Standard Deviation 5.4
15 score on a scale
Standard Deviation 8

SECONDARY outcome

Timeframe: At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart

Evaluate AD severity, this is a 30 point scale from 0-30, with higher scores representing better performance.

Outcome measures

Outcome measures
Measure
High Dose Levetiracetam
n=9 Participants
levetiracetam given at a dose of 7.5mg/kg over 20 minutes
Low Dose Levetiracetam
n=9 Participants
Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
Placebo Administration
n=9 Participants
Saline administration via IV infusion over 20 min
Montreal Cognitive Assessment (MoCA)
21.4 score on a scale
Standard Deviation 1.7
21.4 score on a scale
Standard Deviation 3
20.4 score on a scale
Standard Deviation 4.1

SECONDARY outcome

Timeframe: At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*

Evaluate visuo-spatial changes, outcome is total time to complete a task of connecting items (either numbers in trails A, or numbers alternating with letters in Trails B). A longer time indicates worse performance.

Outcome measures

Outcome measures
Measure
High Dose Levetiracetam
n=9 Participants
levetiracetam given at a dose of 7.5mg/kg over 20 minutes
Low Dose Levetiracetam
n=9 Participants
Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
Placebo Administration
n=9 Participants
Saline administration via IV infusion over 20 min
Trial Making Test Parts A & B
Trails A
44.1 seconds
Standard Deviation 14.7
47.1 seconds
Standard Deviation 25.9
48.9 seconds
Standard Deviation 24.1
Trial Making Test Parts A & B
Trails B
147.3 seconds
Standard Deviation 44.4
138.9 seconds
Standard Deviation 45.3
153.5 seconds
Standard Deviation 64.1

SECONDARY outcome

Timeframe: At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*

Evaluate memory changes in AD. Phonemic fluency refers to the number of items generated in one minute beginning with a specific letter. A higher score indicates more items and better performance. There is no maximum score. Category fluency refers to the number of items generated belonging to a specific category (such as animals), again, more items generated indicates better performance.

Outcome measures

Outcome measures
Measure
High Dose Levetiracetam
n=9 Participants
levetiracetam given at a dose of 7.5mg/kg over 20 minutes
Low Dose Levetiracetam
n=9 Participants
Levetiracetam given at a dose of 2.5mg/kg over 20 minutes
Placebo Administration
n=9 Participants
Saline administration via IV infusion over 20 min
Phonemic & Category Fluency Test
Phonemic fluency
34.4 Correct Items
Standard Deviation 12.5
34 Correct Items
Standard Deviation 9.5
34.4 Correct Items
Standard Deviation 13.2
Phonemic & Category Fluency Test
Animal fluency
13.4 Correct Items
Standard Deviation 5.5
13.1 Correct Items
Standard Deviation 3.7
12.4 Correct Items
Standard Deviation 5.7

Adverse Events

High Dose Levetiracetam

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

Low Dose Levetiracetam

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

Placebo Administration

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

Dr. Daniel Press

Beth Israel Deaconess Medical Center

Phone: 617-667-4074

Results disclosure agreements

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