Trial Outcomes & Findings for Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI) (NCT NCT01044758)

Results Overview

Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

2 weeks

Results posted on

2017-08-21

Participant Flow

Data for the 125mg BID treatment cohort was collected first. Analysis showed no effects of treatment order. As a result, data was collapsed and analyzed irrespective of order across all doses. All subsequent data analyses are thus provided collapsed across treatment orders in all reporting on this study, including the results reported here.

Participant milestones

Participant milestones
Measure	aMCI_62.5mg Drug First, Then Placebo Amnestic MCI: 62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	aMCI_Placebo First, Then 62.5mg Drug Amnestic MCI: Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)	aMCI_125mg Drug First, Then Placebo Amnestic MCI: 125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	aMCI_Placebo First, Then 125mg Drug Amnestic MCI: Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)	aMCI_250mg Drug First, Then Placebo Amnestic MCI: 250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	aMCI_Placebo First, Then 250mg Drug Amnestic MCI: Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)	Control_Placebo First, Then Placebo Healthy control: placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)
Overall Study STARTED	12	12	11	12	11	11	27
Overall Study COMPLETED	8	12	7	10	9	8	17
Overall Study NOT COMPLETED	4	0	4	2	2	3	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	aMCI_62.5mg Drug First, Then Placebo n=8 Participants Amnestic MCI: 62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	aMCI_Placebo First, Then 62.5mg Drug n=12 Participants Amnestic MCI: Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)	aMCI_125mg Drug First, Then Placebo n=7 Participants Amnestic MCI: 125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	aMCI_Placebo First, Then 125mg Drug n=10 Participants Amnestic MCI: Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)	aMCI_250mg Drug First, Then Placebo n=9 Participants Amnestic MCI: 250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	aMCI_Placebo First, Then 250mg Drug n=8 Participants Amnestic MCI: Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)	Control_Placebo First, Then Placebo n=17 Participants Healthy control placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	1 Participants n=30 Participants	1 Participants n=3 Participants	7 Participants n=6 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants	10 Participants n=107 Participants	5 Participants n=206 Participants	10 Participants n=7 Participants	8 Participants n=31 Participants	7 Participants n=30 Participants	16 Participants n=3 Participants	64 Participants n=6 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	5 Participants n=7 Participants	5 Participants n=31 Participants	6 Participants n=30 Participants	8 Participants n=3 Participants	41 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	6 Participants n=107 Participants	1 Participants n=206 Participants	5 Participants n=7 Participants	4 Participants n=31 Participants	2 Participants n=30 Participants	9 Participants n=3 Participants	30 Participants n=6 Participants
Region of Enrollment United States	8 participants n=99 Participants	12 participants n=107 Participants	7 participants n=206 Participants	10 participants n=7 Participants	9 participants n=31 Participants	8 participants n=30 Participants	17 participants n=3 Participants	71 participants n=6 Participants

PRIMARY outcome

Timeframe: 2 weeks

Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.

Outcome measures

Outcome measures
Measure	aMCI_62.5 n=20 Participants 62.5 mg levetiracetam twice daily for two weeks	aMCI_62.5 Placebo n=20 Participants 62.5mg levetiracetam placebo comparator	aMCI_125 n=17 Participants 125 mg Levetiracetam twice daily for two weeks.	aMCI_125 Placebo n=17 Participants 125mg levetiracetam placebo comparator	aMCI_250 n=17 Participants 250mg levetiracetam twice daily for two weeks	aMCI_250 Placebo n=17 Participants 250mg levetiracetam placebo comparator	Age Matched Control n=17 Participants Placebo capsule twice daily for two weeks
Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI	-0.1203 mean beta coefficient Standard Error 0.3475	0.4353 mean beta coefficient Standard Error 0.2215	-0.2238 mean beta coefficient Standard Error 0.1747	0.8814 mean beta coefficient Standard Error 0.3798	0.3928 mean beta coefficient Standard Error 0.2366	0.4825 mean beta coefficient Standard Error 0.1954	-.02507 mean beta coefficient Standard Error .2238

SECONDARY outcome

Timeframe: 2 weeks

Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance.