Alzheimer DiseasePhase 2LAPSENCT04004702
Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE)
A Phase 2 study testing Levetiracetam in people with Alzheimer Disease, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
Patients with Alzheimer's disease (AD) are increasingly recognized to have seizures in addition to cognitive decline. Seizures may contribute to memory problems as well as other symptoms common in AD like agitation, depression, or apathy. These symptoms are collectively called neuro-psychiatric symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the National Institute of Aging-Alzheimer's Association criteria for probable AD
- Twelve-item Neuropsychiatric Inventory with score 4 or greater
- MMSE <26
- Stable doses current medications, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry
- Reliable caregiver willing and available to assist with medication administration, outcome measures
- MRI completed with no evidence of potential seizure focus as outlined in the exclusion criteria
Who cannot join
- Imaging suggestive of potential seizure focus or alternative cause of dementia
- Previous Epilepsy diagnosis
- Use of anti-epileptic medication for any indication within previous three months
- History of head trauma with loss of consciousness more than 30 minutes
- Alcohol/Substance abuse within 5 years of dementia onset or previous 5 years
- History of Korsakoff's syndrome
Show all 15Show fewer
- History of encephalitis/meningitis
- Female participant who is pregnant, lactating or planning pregnancy during trial
- Scheduled elective surgery or other procedures requiring general anesthesia during the trial
- Participant with life expectancy of less than 12 months
- Any cancer requiring current chemotherapy
- Known allergy or history of previous adverse reaction to levetiracetam
- Major depression or other significant behavioral disturbance preceding Alzheimer's Disease diagnosis
- Enrollment in another clinical treatment trial
- Laboratory evidence of an alternative cause of dementia or which might preclude treatment, including untreated vitamin B12 deficiency, untreated hypothyroidism, syphilis, positive human immunodeficiency virus testing, end-stage renal disease on dialysis, significant renal impairment (creatinine clearance <75 ml/minute), or liver function tests >2x upper limit of normal within the preceding three months
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Timothy R Malone, MD, 301-295-4771, timothy.r.malone5.mil@mail.mil
Timothy R Malone, MD
About this study
Official title: Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE) - A Phase II Exploratory Study
Patients with Alzheimer's disease (AD) are increasingly recognized to have seizures in addition to cognitive decline. Seizures may contribute to memory problems as well as other symptoms common in AD like agitation, depression, or apathy. These symptoms are collectively called neuro-psychiatric symptoms. Studies of magnetic resonance imaging (MRI) in patients with AD have suggested that injury to certain parts of the brain can cause these neuro-psychiatric symptoms. Based on this evidence, the investigators hypothesize that seizures can also cause neuro-psychiatric symptoms in patients with AD and may be related to the injury seen on MRI.
The current study will follow participants for 1 year and will involve participants with AD who also have neuro-psychiatric symptoms. Participants will be examined with three brain wave studies to assess for seizure-like activity. Participants with seizure-like activity will all receive levetiracetam for 1 year. All participants will have their neuro-psychiatric symptoms, cognitive abilities, quality of life, and AD severity assessed throughout the year. The investigators plan to determine if levetiracetam changes the severity of the participants' neuro-psychiatric symptoms compared to their baseline as well as compared to participants without seizure-like activity. 65 participants will need to be recruited to test the study hypotheses. The study will take place at Walter Reed National Military Medical Center.
Read the detailed description
Alzheimer's Disease (AD) has long been known to carry an increased risk of seizure, with early estimates suggesting patients with AD have a 10-22% risk at least one unprovoked seizure and an 8- to 10-fold higher seizure rate over the general population. Retrospective data has suggested that the onset of both clinical seizure and abnormal discharge on electroencephalogram (EEG) may cluster around or even precede the onset of cognitive decline. With extended EEG and/or 1-hour magnetoencephalogram (MEG), up to 42% of patients with AD have evidence of subclinical seizure or epileptiform discharges, two-thirds of which were identified only during sleep. Recent evidence has also found a much higher incidence of dyscognitive seizure (47%) and other nonconvulsive semiologies (55%) than previously reported, including jamais vu, déjà vu, sensory phenomenon, speech arrest/aphasia, and amnestic spells.
A particularly problematic aspect of dementia in general and AD in particular is neuropsychiatric symptoms. Neuropsychiatric symptoms increase with duration and severity of dementia, observed in as much as 60-90% of these patients. To some extent, neuropsychiatric symptoms may also be associated with focal dysfunction, particularly of the non-dominant fronto-temporal lobes. Seizure or transient epileptiform discharges, then, might explain some of the neuropsychiatric manifestations associated with AD, especially since the most common areas of discharge are the fronto-temporal lobes in AD. Neuropsychiatric symptoms and their causes are of particular concern in the management of patients with AD given the strain on patients and families and their high association with nursing home placement.
This study will complete up to 3 serial EEGs on each participant, and all participants with epileptiform activity identified on EEG will be started on levetiracetam. All participants will be followed with serial neuro-psychiatric symptom, cognitive, severity, and quality-of-life metrics in order to analyze the effect of levetiracetam on these measures over 1 year.
- Conditions
- Alzheimer Disease
- Being tested
- Levetiracetam
- Keywords
- neuro-psychiatric symptoms
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Levetiracetam 500mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | All patients with epileptiform activity on initial screening EEG will receive levetiracetam for 1 year Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropsychiatric Inventory Score (NPI)
Neuropsychiatric Symptom Metric
Measured: Assessed at enrollment, week 7, week 15, week 27, and month 12
Secondary outcomes (4)
Change in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Patient/Informant AD Severity Metric
Measured: Assessed at enrollment, week 7, week 15, week 27, and month 12
Change in Alzheimer's Disease Cooperative study - Clinical Global Impression of Change (ADCS-CGIC)
Clinician AD Severity Metric
Measured: Assessed at enrollment, week 7, week 15, week 27, and month 12
Change in EuroQol 5-Dimension (EQ-5D)
Quality of Life Metric
Measured: Assessed at enrollment, week 7, week 15, week 27, and month 12
Change in Mini-Mental State Exam (MMSE)
Cognitive Ability Metric
Measured: Assessed at enrollment, week 7, week 15, week 27, and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants with clinical Alzheimer's disease and neuro-psychiatric symptoms will all be assessed with electroencephalogram, and all participants with epileptiform discharges will receive levetiracetam. Those without epileptiform discharges will be followed with serial inventories of symptom severity and functioning, but will not receive experimental treatment nor placebo.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy R Malone, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004702
- Sponsor's protocol ID
- 06272019
- Acronym
- LAPSE
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauser WA, Morris ML, Heston LL, Anderson VE. Seizures and myoclonus in patients with Alzheimer's disease. Neurology. 1986 Sep;36(9):1226-30. doi: 10.1212/wnl.36.9.1226.
PubMed 3092131Romanelli MF, Morris JC, Ashkin K, Coben LA. Advanced Alzheimer's disease is a risk factor for late-onset seizures. Arch Neurol. 1990 Aug;47(8):847-50. doi: 10.1001/archneur.1990.00530080029006.
PubMed 2375689Volicer L, Smith S, Volicer BJ. Effect of seizures on progression of dementia of the Alzheimer type. Dementia. 1995 Sep-Oct;6(5):258-63. doi: 10.1159/000106956.
PubMed 8528372Mendez M, Lim G. Seizures in elderly patients with dementia: epidemiology and management. Drugs Aging. 2003;20(11):791-803. doi: 10.2165/00002512-200320110-00001.
PubMed 12964886Amatniek JC, Hauser WA, DelCastillo-Castaneda C, Jacobs DM, Marder K, Bell K, Albert M, Brandt J, Stern Y. Incidence and predictors of seizures in patients with Alzheimer's disease. Epilepsia. 2006 May;47(5):867-72. doi: 10.1111/j.1528-1167.2006.00554.x.
PubMed 16686651Palop JJ, Mucke L. Epilepsy and cognitive impairments in Alzheimer disease. Arch Neurol. 2009 Apr;66(4):435-40. doi: 10.1001/archneurol.2009.15. Epub 2009 Feb 9.
PubMed 19204149Scarmeas N, Honig LS, Choi H, Cantero J, Brandt J, Blacker D, Albert M, Amatniek JC, Marder K, Bell K, Hauser WA, Stern Y. Seizures in Alzheimer disease: who, when, and how common? Arch Neurol. 2009 Aug;66(8):992-7. doi: 10.1001/archneurol.2009.130.
PubMed 19667221Campion D, Flaman JM, Brice A, Hannequin D, Dubois B, Martin C, Moreau V, Charbonnier F, Didierjean O, Tardieu S, et al. Mutations of the presenilin I gene in families with early-onset Alzheimer's disease. Hum Mol Genet. 1995 Dec;4(12):2373-7. doi: 10.1093/hmg/4.12.2373.
PubMed 8634712Fox NC, Kennedy AM, Harvey RJ, Lantos PL, Roques PK, Collinge J, Hardy J, Hutton M, Stevens JM, Warrington EK, Rossor MN. Clinicopathological features of familial Alzheimer's disease associated with the M139V mutation in the presenilin 1 gene. Pedigree but not mutation specific age at onset provides evidence for a further genetic factor. Brain. 1997 Mar;120 ( Pt 3):491-501. doi: 10.1093/brain/120.3.491.
PubMed 9126060Lopera F, Ardilla A, Martinez A, Madrigal L, Arango-Viana JC, Lemere CA, Arango-Lasprilla JC, Hincapie L, Arcos-Burgos M, Ossa JE, Behrens IM, Norton J, Lendon C, Goate AM, Ruiz-Linares A, Rosselli M, Kosik KS. Clinical features of early-onset Alzheimer disease in a large kindred with an E280A presenilin-1 mutation. JAMA. 1997 Mar 12;277(10):793-9.
PubMed 9052708Axelman K, Basun H, Lannfelt L. Wide range of disease onset in a family with Alzheimer disease and a His163Tyr mutation in the presenilin-1 gene. Arch Neurol. 1998 May;55(5):698-702. doi: 10.1001/archneur.55.5.698.
PubMed 9605727Janssen JC, Hall M, Fox NC, Harvey RJ, Beck J, Dickinson A, Campbell T, Collinge J, Lantos PL, Cipolotti L, Stevens JM, Rossor MN. Alzheimer's disease due to an intronic presenilin-1 (PSEN1 intron 4) mutation: A clinicopathological study. Brain. 2000 May;123 ( Pt 5):894-907. doi: 10.1093/brain/123.5.894.
PubMed 10775535Cabrejo L, Guyant-Marechal L, Laquerriere A, Vercelletto M, De la Fourniere F, Thomas-Anterion C, Verny C, Letournel F, Pasquier F, Vital A, Checler F, Frebourg T, Campion D, Hannequin D. Phenotype associated with APP duplication in five families. Brain. 2006 Nov;129(Pt 11):2966-76. doi: 10.1093/brain/awl237. Epub 2006 Sep 7.
PubMed 16959815Irizarry MC, Jin S, He F, Emond JA, Raman R, Thomas RG, Sano M, Quinn JF, Tariot PN, Galasko DR, Ishihara LS, Weil JG, Aisen PS. Incidence of new-onset seizures in mild to moderate Alzheimer disease. Arch Neurol. 2012 Mar;69(3):368-72. doi: 10.1001/archneurol.2011.830.
PubMed 22410444Mendez MF, Catanzaro P, Doss RC, ARguello R, Frey WH 2nd. Seizures in Alzheimer's disease: clinicopathologic study. J Geriatr Psychiatry Neurol. 1994 Oct-Dec;7(4):230-3. doi: 10.1177/089198879400700407.
PubMed 7826492
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE) - A Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT04004702
- Acronym / sponsor ID
- LAPSE / 06272019
- Conditions
- Alzheimer Disease
- Keywords
- neuro-psychiatric symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Alzheimer's disease (AD) are increasingly recognized to have seizures in addition to cognitive decline. Seizures may contribute to memory problems as well as other symptoms common in AD like agitation, depression, or apathy. These symptoms are collectively called neuro-psychiatric symptoms. Studies of magnetic resonance imaging (MRI) in patients with AD have suggested that injury to certain parts of the brain can cause these neuro-psychiatric symptoms. Based on this evidence, the investigators hypothesize that seizures can also cause neuro-psychiatric symptoms in patients with AD and may be related to the injury seen on MRI.
The current study will follow participants for 1 year and will involve participants with AD who also have neuro-psychiatric symptoms. Participants will be examined with three brain wave studies to assess for seizure-like activity. Participants with seizure-like activity will all receive levetiracetam for 1 year. All participants will have their neuro-psychiatric symptoms, cognitive abilities, quality of life, and AD severity assessed throughout the year. The investigators plan to determine if levetiracetam changes the severity of the participants' neuro-psychiatric symptoms compared to their baseline as well as compared to participants without seizure-like activity. 65 participants will need to be recruited to test the study hypotheses. The study will take place at Walter Reed National Military Medical Center.
Detailed description
Alzheimer's Disease (AD) has long been known to carry an increased risk of seizure, with early estimates suggesting patients with AD have a 10-22% risk at least one unprovoked seizure and an 8- to 10-fold higher seizure rate over the general population. Retrospective data has suggested that the onset of both clinical seizure and abnormal discharge on electroencephalogram (EEG) may cluster around or even precede the onset of cognitive decline. With extended EEG and/or 1-hour magnetoencephalogram (MEG), up to 42% of patients with AD have evidence of subclinical seizure or epileptiform discharges, two-thirds of which were identified only during sleep. Recent evidence has also found a much higher incidence of dyscognitive seizure (47%) and other nonconvulsive semiologies (55%) than previously reported, including jamais vu, déjà vu, sensory phenomenon, speech arrest/aphasia, and amnestic spells.
A particularly problematic aspect of dementia in general and AD in particular is neuropsychiatric symptoms. Neuropsychiatric symptoms increase with duration and severity of dementia, observed in as much as 60-90% of these patients. To some extent, neuropsychiatric symptoms may also be associated with focal dysfunction, particularly of the non-dominant fronto-temporal lobes. Seizure or transient epileptiform discharges, then, might explain some of the neuropsychiatric manifestations associated with AD, especially since the most common areas of discharge are the fronto-temporal lobes in AD. Neuropsychiatric symptoms and their causes are of particular concern in the management of patients with AD given the strain on patients and families and their high association with nursing home placement.
This study will complete up to 3 serial EEGs on each participant, and all participants with epileptiform activity identified on EEG will be started on levetiracetam. All participants will be followed with serial neuro-psychiatric symptom, cognitive, severity, and quality-of-life metrics in order to analyze the effect of levetiracetam on these measures over 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with clinical Alzheimer's disease and neuro-psychiatric symptoms will all be assessed with electroencephalogram, and all participants with epileptiform discharges will receive levetiracetam. Those without epileptiform discharges will be followed with serial inventories of symptom severity and functioning, but will not receive experimental treatment nor placebo.
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: LevetiracetamAll patients with epileptiform activity on initial screening EEG will receive levetiracetam for 1 year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the National Institute of Aging-Alzheimer's Association criteria for probable AD
- Twelve-item Neuropsychiatric Inventory with score 4 or greater
- MMSE <26
- Stable doses current medications, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry
- Reliable caregiver willing and available to assist with medication administration, outcome measures
Key exclusion criteria (15 listed)
- Imaging suggestive of potential seizure focus or alternative cause of dementia
- Previous Epilepsy diagnosis
- Use of anti-epileptic medication for any indication within previous three months
- History of head trauma with loss of consciousness more than 30 minutes
- Alcohol/Substance abuse within 5 years of dementia onset or previous 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamAlso: KeppraLevetiracetam 500mg twice a day | Drug | Levetiracetam |
Primary outcome
Change in Neuropsychiatric Inventory Score (NPI)
Time frame: Assessed at enrollment, week 7, week 15, week 27, and month 12
Neuropsychiatric Symptom Metric
4 secondary outcomes
Change in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Time frame: Assessed at enrollment, week 7, week 15, week 27, and month 12
Change in Alzheimer's Disease Cooperative study - Clinical Global Impression of Change (ADCS-CGIC)
Time frame: Assessed at enrollment, week 7, week 15, week 27, and month 12
Change in EuroQol 5-Dimension (EQ-5D)
Time frame: Assessed at enrollment, week 7, week 15, week 27, and month 12
Change in Mini-Mental State Exam (MMSE)
Time frame: Assessed at enrollment, week 7, week 15, week 27, and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 3092131Hauser WA, Morris ML, Heston LL, Anderson VE. Seizures and myoclonus in patients with Alzheimer's disease. Neurology. 1986 Sep;36(9):1226-30. doi: 10.1212/wnl.36.9.1226.
- Background: PubMed 2375689Romanelli MF, Morris JC, Ashkin K, Coben LA. Advanced Alzheimer's disease is a risk factor for late-onset seizures. Arch Neurol. 1990 Aug;47(8):847-50. doi: 10.1001/archneur.1990.00530080029006.
- Background: PubMed 8528372Volicer L, Smith S, Volicer BJ. Effect of seizures on progression of dementia of the Alzheimer type. Dementia. 1995 Sep-Oct;6(5):258-63. doi: 10.1159/000106956.
- Background: PubMed 12964886Mendez M, Lim G. Seizures in elderly patients with dementia: epidemiology and management. Drugs Aging. 2003;20(11):791-803. doi: 10.2165/00002512-200320110-00001.
- Background: PubMed 16686651Amatniek JC, Hauser WA, DelCastillo-Castaneda C, Jacobs DM, Marder K, Bell K, Albert M, Brandt J, Stern Y. Incidence and predictors of seizures in patients with Alzheimer's disease. Epilepsia. 2006 May;47(5):867-72. doi: 10.1111/j.1528-1167.2006.00554.x.
- Background: PubMed 19204149Palop JJ, Mucke L. Epilepsy and cognitive impairments in Alzheimer disease. Arch Neurol. 2009 Apr;66(4):435-40. doi: 10.1001/archneurol.2009.15. Epub 2009 Feb 9.
- Background: PubMed 19667221Scarmeas N, Honig LS, Choi H, Cantero J, Brandt J, Blacker D, Albert M, Amatniek JC, Marder K, Bell K, Hauser WA, Stern Y. Seizures in Alzheimer disease: who, when, and how common? Arch Neurol. 2009 Aug;66(8):992-7. doi: 10.1001/archneurol.2009.130.
- Background: PubMed 8634712Campion D, Flaman JM, Brice A, Hannequin D, Dubois B, Martin C, Moreau V, Charbonnier F, Didierjean O, Tardieu S, et al. Mutations of the presenilin I gene in families with early-onset Alzheimer's disease. Hum Mol Genet. 1995 Dec;4(12):2373-7. doi: 10.1093/hmg/4.12.2373.
- Background: PubMed 9126060Fox NC, Kennedy AM, Harvey RJ, Lantos PL, Roques PK, Collinge J, Hardy J, Hutton M, Stevens JM, Warrington EK, Rossor MN. Clinicopathological features of familial Alzheimer's disease associated with the M139V mutation in the presenilin 1 gene. Pedigree but not mutation specific age at onset provides evidence for a further genetic factor. Brain. 1997 Mar;120 ( Pt 3):491-501. doi: 10.1093/brain/120.3.491.
- Background: PubMed 9052708Lopera F, Ardilla A, Martinez A, Madrigal L, Arango-Viana JC, Lemere CA, Arango-Lasprilla JC, Hincapie L, Arcos-Burgos M, Ossa JE, Behrens IM, Norton J, Lendon C, Goate AM, Ruiz-Linares A, Rosselli M, Kosik KS. Clinical features of early-onset Alzheimer disease in a large kindred with an E280A presenilin-1 mutation. JAMA. 1997 Mar 12;277(10):793-9.
- Background: PubMed 9605727Axelman K, Basun H, Lannfelt L. Wide range of disease onset in a family with Alzheimer disease and a His163Tyr mutation in the presenilin-1 gene. Arch Neurol. 1998 May;55(5):698-702. doi: 10.1001/archneur.55.5.698.
- Background: PubMed 10775535Janssen JC, Hall M, Fox NC, Harvey RJ, Beck J, Dickinson A, Campbell T, Collinge J, Lantos PL, Cipolotti L, Stevens JM, Rossor MN. Alzheimer's disease due to an intronic presenilin-1 (PSEN1 intron 4) mutation: A clinicopathological study. Brain. 2000 May;123 ( Pt 5):894-907. doi: 10.1093/brain/123.5.894.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R Malone, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam in people with Alzheimer Disease, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy R Malone, MD (301-295-4771, timothy.r.malone5.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropsychiatric Inventory Score (NPI) (time frame: Assessed at enrollment, week 7, week 15, week 27, and month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004702, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.