CompletedPhase 4Results posted

Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia

A Prospective, Phase 4, Open-Label, Twelve-Week Study to Examine the Cognitive Impact and Tolerability of Levetiracetam (Keppra) in Elderly Patients With Seizures of Partial Onset

Lead sponsor

Drexel University College of Medicine

Asset

Levetiracetam

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s, Mixed / unspecified dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoints

•Mini-Mental State Examination (MMSE)•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDKEPPRA

NCT IDNCT01318408

Secondary IDWIRB # 20061543UCB pharma grant to DUCOM

Timeline

Milestones

Study start2006-11 (month precision)

Primary completion2008-03actual (month precision)

Study completion2008-03actual (month precision)

Study first posted2011-03-18estimated

Results first posted2015-06-23estimated

Last update posted2018-10-12actual

Assets

Drug assets

Levetiracetam

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’sMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Able to give written informed consent

•Meet validated clinical criteria for Alzheimer's disease, mixed dementia or MCI

•Age range greater than or equal to 60 years

•Stable general medical condition as assessed by the investigator

•Seizures which are partial in onset (with or without secondary generalization)

•Subjects with 4 or fewer seizures per month

•MMSE score of less than 28 at baseline

•Patients who are currently being treated with anticonvulsants or those with new onset seizures

Exclusion criteria

•Patients with other clinically significant organic or neurological diseases. Patients considered medically unstable

•Patients in end stage renal disease requiring hemodialysis

•Patients with a known hypersensitivity to Levetiracetam

•Patients with primary generalized epilepsy

•Patients with brain tumors or other significant CNS abnormalities that are the primary cause of the seizures

•Patients with a history of status epilepticus

•Patients with severe psychiatric diagnoses or severe behavioral problems

•Dementia patients lacking a caregiver.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Global cognition

4 endpoints

Primary/protocol endpoint

MMSE at Baseline and at Three (3) Months.

Time frame:Baseline and Three months

Mini-Mental State Examination (MMSE)

ratio, descriptive

Primary/protocol endpoint

ADAS-cog at Baseline and at 3 Months.

Time frame:Baseline and Three (3) months

ADAS-Cog

descriptive

Primary/registry result

MMSE at Baseline and at Three (3) Months.

Time frame:Baseline and Three months

Mini-Mental State Examination (MMSE)

ratio, descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Open LabelBaselinen=24 Participants	18.2	7.9
Change at 3 Monthsn=24 Participants	2.2	3.0

p.01Wilcoxon (Mann-Whitney)

Primary/registry result

ADAS-cog at Baseline and at 3 Months.

Time frame:Baseline and Three (3) months

ADAS-Cog

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Open LabelBaselinen=24 Participants	25.5	13.8
Change at 3 monthsn=24 Participants	-4.3	6.4

p.02Wilcoxon (Mann-Whitney)

Function / daily living

2 endpoints

Other/protocol endpoint

Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated

Time frame:12 weeks

descriptive

Other_pre_specified/registry result

Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated

Time frame:12 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Ritchie K, Touchon J. Mild cognitive impairment: conceptual basis and current nosological status. Lancet. 2000 Jan 15;355(9199):225-8. doi: 10.1016/S0140-6736(99)06155-3. No abstract available.
PMID10675135via BACKGROUND

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.