N/A
N=9
Seizure Activity in Alzheimer's Disease
Alzheimer's Disease · Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01554683 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Evaluable fMRI Scans — 9; 9; 9; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low/High/Placebo Dose Keppra (Levetiracetam) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Evaluable fMRI Scans |
9; 9; 9; 9; 9; 9 | — |
| SECONDARY Free and Cued Selective Reminding Test |
13.4; 14.3; 15 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
21.4; 21.4; 20.4 | — |
| SECONDARY Trial Making Test Parts A & B |
44.1; 47.1; 48.9; 147.3; 138.9; 153.5 | — |
| SECONDARY Phonemic & Category Fluency Test |
34.4; 34; 34.4; 13.4; 13.1; 12.4 | — |
Summary
The main purpose of this research project is to study how seizure-like activity affects the blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can change memory and thinking ability, as happens in Alzheimer's disease. The investigators are using a study drug called Levetiracetam, which helps control seizure-like activity to see if it can help change the abnormal blood flow in the brain that is seen in some people with Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria
- Meets the NINCDS-ADRDA criteria for probable Alzheimer's disease
- Mild AD (MMSE ≥ 20)
- Age >= 50 years
- English as first language
Exclusion Criteria
- A history of seizures prior to the onset of AD
- Familial Alzheimer's Disease due to known genetic mutations
- Current use of an antiepileptic medication
- Current use of a medication known to lower seizure threshold (e.g. bupropion or a neuroleptic)
- Presence of parkinsonism
- Significant cerebrovascular disease
- Other Central Nervous System disease (e.g. stroke, severe traumatic brain injury)
- Major depression or other psychiatric or behavioral disorders (psychosis, agitation)
- Medical contraindication to MRI (e.g. pacemaker, intraocular or intracranial metallic objects)
- Severe claustrophobia or inability to lie flat for MRI
- Known allergy to levetiracetam, or history of previous adverse reaction to levetiracetam
- Serum creatinine >= 2
- A score of >9 on the Geriatric Depression Scale
Data sourced from ClinicalTrials.gov (NCT01554683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.