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. 2021 May 11;2021(5):CD011922. doi: 10.1002/14651858.CD011922.pub4

Cumbo 2010.

Study characteristics
Methods A prospective, randomized, three‐arm parallel‐group clinical trial
Participants Inclusion criteria: mild to moderate disease (MMSE score: 10 to 26), age between 60 and 90 years, educational level ≥ 5 years, a diagnosis of partial epilepsy according to the International League Against Epilepsy diagnostic scheme, and a caregiver who could ensure compliance with treatment and provide the information required for psychometric assessments.
Exclusion criteria: history of primary neurological or psychiatric disease other than AD, history of seizures experienced prior to the development of AD, drug or alcohol abuse, clinically significant or unstable medical or surgical disorders that could influence the outcome of the study, previous treatment for epilepsy, concomitant treatment with antidepressants or neuroleptics, use of investigational drugs, and refusal to give informed consent in writing.
A total of 95 people with AD and epileptic seizures (41 males, 54 females) with a mean age of 71.75 years (range: 65 to 82 years) and a mean duration of education of 6.3 years (range: 5 to 17 years) living in the community were included in the study.
Participants were randomly assigned with an AED as monotherapy: 38 were administered LEV, 28 PB, and 29 LTG.
Interventions This study comprised a 4‐week dose adjustment period followed by a 12‐month dose evaluation period.
During the treatment periods, participants received LEV, PB, or LTG and were titrated to an effective dose. No participant was previously exposed to another AED. The initial target dosage of LEV was 500 mg/day, increased weekly by 500 mg/day; for PB, it was 50 mg/day increased weekly by 50 mg/day; and for LTG, it was 25 mg/day increased weekly by 25 mg/day. Thereafter, the dosage was individually adjusted. The mean daily dose of LEV monotherapy was 956 mg (range: 500 to 2000 mg/day). The mean daily dose of PB monotherapy was 90 mg/day (range: 50 to 100 mg/day). The mean daily dose of LTG monotherapy was 57.5 mg/day (range: 25 to 100 mg/day).
Outcomes Primary outcomes: percentage of participants achieving at least 50% and 100% (seizure‐freedom) reduction in seizure frequency; adverse events.
Secondary outcomes: changes in MMSE score; changes in ADAS‐Cog score; changes in Cornell scale for depression.
Notes All participants had concomitant cholinesterase inhibitor therapy for AD. Other concomitant medications, including diuretics, antihypertensives, lipid‐reducing agents, and antidiabetic drugs, started prior to the baseline visit were allowed during the study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Each participant was randomly assigned to be treated with an AED as monotherapy: 38 were administered LEV, 28 PB, and 29 LTG. Further details were not provided.
Allocation concealment (selection bias) Unclear risk The details were not provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk The details were not provided.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk The details were not provided.
Incomplete outcome data (attrition bias)
All outcomes Low risk 83 participants (35 on LEV, 23 on PB, 25 on LTG) (87%) completed the study. The reasons for dropouts were given.
Selective reporting (reporting bias) Low risk The outcomes reported in the methods and results were consistent; and all important outcomes expected were reported.
Other bias High risk Minimum necessary sample size was not calculated.

AD: Alzheimer's disease; ADAS‐Cog: Alzheimer’s Disease Assessment Scale‐Cognitive; AED: antiepileptic drug; LEV: levetiracetam; LTG: lamotrigine; MMSE: Mini Mental State Examination; PB: phenobarbital

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