Alzheimer DiseasePhase 2ILiADNCT03489044
An Investigation of Levetiracetam in Alzheimer's Disease
A Phase 2 study testing Levetiracetam in people with Alzheimer Disease and Epilepsy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's disease (AD) in a Phase 2 Clinical Trial. Levetiracetam is an established anti-epileptic medication that has been approved by NICE (UK) as a first line treatment for focal epilepsy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Epilepsy
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2018to 21 Mar 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, 50 years or above.
- Diagnosed with mild to moderate AD (MMSE 10 to 26)
- Meets the National Institute of Aging-Alzheimer's Association criteria for probable AD (2011)
- Stable dose of current regular medication, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter. Acceptable forms of contraception include: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); total abdominal hysterectomy; barrier methods of contraception (condom or occlusive cap with spermicide); male sterilisation, if the vasectomised partner is the sole partner for the subject; true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception).
- Participant has clinically acceptable blood and urine test results (creatinine clearance >75 ml/minute; liver function tests <2x upper limit of normal) and ECG that does not demonstrate conduction block or significant ischaemia within three months of enrolment.
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- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- Reliable carer willing and available to assist with medication administration as well as to accompany participants during any home visits.
Who cannot join
- Pre-existing diagnosis of epilepsy
- Clinical or laboratory evidence of a cause other than AD as a cause of their dementia
- Laboratory evidence of significant renal impairment (creatinine clearance <75 ml/minute) or liver dysfunction (liver function tests >2x upper limit of normal) within the preceding three months
- Visual or motor impairment that investigator deems severe enough to impair ability to complete computerised based touch screen task
- Use of anti-epileptic medication for any indication (epilepsy, pain or migraine) within previous three months
- Other severe neurological or medical condition. Examples include, significant stroke, heart failure, chronic renal failure, chronic liver failure within last 3 months
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- Major depression or other significant behavioural disturbance
- Known allergy to Levetiracetam or history of previous adverse reaction to Levetiracetam
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Participant with life expectancy of less than 6 months, or is inappropriate for placebo medication.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks Carer of participant with AD
- Carer has significant medical illness that will preclude adequate data capture during the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nuffield Department of Clinical Neuroscience
Oxford, Oxfordshire, OX39DU
About this study
Official title: An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a Proof of Concept Study
The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's disease (AD) in a Phase 2 Clinical Trial.
Levetiracetam is an established anti-epileptic medication that has been approved by NICE (UK) as a first line treatment for focal epilepsy. Levetiracetam is now generic and acts, as all anti-epileptic medications do, by stabilising neuronal networks. However, Levetiracetam appears unique amongst the anti-epileptic medications in being able to stabilise aberrant neuronal networks in Alzheimer's disease. In both animal models of AD and in patients with mild cognitive impairment, Levetiracetam can offer benefit to cognition.
The investigators therefore aim to test whether Levetiracetam, through stabilisation of neuronal networks, may offer benefit to cognition in patients with AD.
Read the detailed description
Lay Summary:
Alzheimer's disease affects around 800,000 people in the UK alone and costs almost £23 billion per year. The only currently licensed treatments for Alzheimer's disease offer modest benefit at best. Seizures are more common in people with Alzheimer's disease and people with Alzheimer's disease may also have evidence of abnormal brainwave activity without having obvious seizures. Seizures may contribute to the loss of nerve cells and abnormal brainwave activity can disrupt thinking and memory. This abnormal electrical activity is therefore a potentially important drug target.
The anti-epileptic drug Levetiracetam can reduce abnormal brainwave activity and reverse memory deficits in a mouse model of Alzheimer's disease. Levetiracetam can also improve memory difficulties seen in people with mild cognitive impairment, a pre-cursor to Alzheimer's disease. Clinical use of Levetiracetam is already widespread and it is recommended by The National Institute of Health and Care Excellence as a first line treatment for seizures. Levetiracetam is generic (off-patent), is not known to interact with any other drugs and is well tolerated. A promising, cheap and safe approach might be to use Levetiracetam as a treatment to help with memory difficulties in Alzheimer's disease.
The proposed project is a proof of concept study. The investigators wish to allocate thirty patients with Alzheimer's disease with no history of previous seizure to initially receive either Levetiracetam or placebo before patients 'cross-over' so that the participants who initially received Levetiracetam are then given placebo and vice-versa. The effect that Levetiracetam has on memory in Alzheimer's disease will be studied using several standardised scales. Tests that the investigators have developed to better detect subtle improvements in thinking will also be used. Patients will have a straightforward, non-invasive test called an electroencephalogram to look at their brainwave activity at the start of the study, as there may be brainwave markers that might help to predict which patients would benefit most from Levetiracetam.
This study evaluates if an anti-epileptic medication can offer meaningful benefit to patients with Alzheimer's disease. If this study is successful, the next step will be to rapidly progress to a larger study to establish whether Levetiracetam may be a useful and cost-effective treatment for patients with Alzheimer's disease.
Main hypothesis:
- Treatment with the anti-epileptic drug Levetiracetam will be of benefit to cognitive deficits in Alzheimer's disease because electrophysiological disruption of neuronal networks contributes to the pathophysiology of the condition.
- Treatment with Levetiracetam at a dose that is routinely utilized in older people with epilepsy will be well tolerated in patients with Alzheimer's disease and, in particular, will not adversely affect mood
- Electroencephalography (EEG) may offer a biomarker to predict which patients with Alzheimer's disease might be especially suited to treatment with Levetiracetam
- Conditions
- Alzheimer Disease, Epilepsy
- Being tested
- Levetiracetam, Placebo Oral Tablet
- Keywords
- Alzheimer, Seizure, Epilepsy, Anti-epileptic drug, Levetiracetam
- Medical subject headings
- Alzheimer Disease, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
To up-titrate Levetiracetam to 500mg (two tablets) twice daily followed by maintenance on Levetiracetam 500mg twice daily for four weeks and then down-titrate to nil over four weeks
Placebo Oral TabletDrug
To up-titrate placebo to two tablets twice daily followed by maintenance on placebo two tablets twice daily for four weeks and then down-titrate to nil over four weeks
| Study group | Role | What they receive |
|---|---|---|
| Active treatment arm (Levetiracetam) | Experimental | When in the active arm, after a baseline visit, participants will up-titrate Levetiracetam in 250mg steps at intervals of one week to Levetiracetam 500mg twice daily (two tablets twice daily). Participants will be maintained on Levetiracetam 500mg bd for four weeks and have a further full assessment at 8 weeks after being on Levetiracetam. Participants will then down-titrate Levetiracetam by 250mg every week until weaned to nil. Receives: Drug: Levetiracetam |
| Control arm (placebo oral tablets) | Placebo comparator | When in the control arm, after a baseline visit, participants will up-titrate placebo (manufactured to look identical to Levetiracetam 250mg) in one tablet steps at intervals of one week to two tablets twice daily. Participants will be maintained on placebo for four weeks and have a further full assessment at 8 weeks after being on placebo. Participants will then down-titrate placebo by one tablet every week until weaned to nil. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Levetiracetam on hippocampal function in patients with Alzheimer's disease as assessed by a computerised test of hippocampal binding
Change from baseline in measures of hippocampal binding on a standardised computer based test. Participants will be shown fractals on a screen, followed by a blank screen. The participants will be then shown one of the fractals they saw previously and a foil. The participants will have to identify which of the fractals they saw initially and then drag that fractal on the screen to the location where it appeared before. The computer will assess whether the participant correctly identifies which fractal had been seen previously and also assess how accurately the participant remembers the location of the previously shown fractal. The investigators will then evaluate whether there are any changes in the accuracy of remembering fractals/fractal position after exposure to Levetiracetam/placebo
Measured: 18 months
Secondary outcomes (5)
Number of participants with treatment related serious adverse events as reported on the serious adverse events proforma
To determine if use of Levetiracetam associates with significant side effects in patients with AD that have not experienced an overt seizure
Measured: 18 months
Effect of Levetiracetam on mood in patients with Alzheimer's disease
Number of participants reporting change from baseline on the Neuropsychiatric Inventory
Measured: 18 months
Effect of Levetiracetam on quality of life in patients with Alzheimer's disease as assessed by their principal carer
Number of participants with a change from baseline on Dementia Severity Rating Scale
Measured: 18 months
Effect of Levetiracetam on quality of life in patients with Alzheimer's disease
Number of participants with a change from baseline on the Euro-QoL (EQ5D) measure
Measured: 18 months
Determining role of the electroencephalogram in patients with Alzheimer's disease
Correlation of electroencephalogram recording with effect of Levetiracetam on cognition as assessed by a computer based test of hippocampal binding
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start28 Oct 2018
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust, Northumberland, Tyne and Wear NHS Foundation Trust, UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Arjune Sen, PhD, FRCPE, Study director, Nuffield Department of Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489044
- Sponsor's protocol ID
- IRAS 203849
- Other IDs
- 2016-003109-32, 2016
- Acronym
- ILiAD
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2018
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is possible that irretrievably anonymised data will be shared with other researchers dependent on securing relevant ethical approval
Publications
Sen A, Akinola M, Tai XY, Symmonds M, Davis Jones G, Mura S, Galloway J, Hallam A, Chan JYC, Koychev I, Butler C, Geddes J, Van Der Putt R, Thompson S, Manohar SG, Frangou E, Love S, McShane R, Husain M. An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a double-blind, placebo-controlled, randomised crossover proof of concept study. Trials. 2021 Jul 31;22(1):508. doi: 10.1186/s13063-021-05404-4.
PubMed 34332638Liu J, Wang LN. Treatment of epilepsy for people with Alzheimer's disease. Cochrane Database Syst Rev. 2021 May 11;5(5):CD011922. doi: 10.1002/14651858.CD011922.pub4.
PubMed 33973646
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03489044
- Acronym / sponsor ID
- ILiAD / IRAS 203849
- Conditions
- Alzheimer Disease, Epilepsy
- Keywords
- Alzheimer, Seizure, Epilepsy, Anti-epileptic drug, Levetiracetam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust, Northumberland, Tyne and Wear NHS Foundation Trust, UCB Pharma
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 5 Apr 2018 (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.
The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's disease (AD) in a Phase 2 Clinical Trial.
Levetiracetam is an established anti-epileptic medication that has been approved by NICE (UK) as a first line treatment for focal epilepsy. Levetiracetam is now generic and acts, as all anti-epileptic medications do, by stabilising neuronal networks. However, Levetiracetam appears unique amongst the anti-epileptic medications in being able to stabilise aberrant neuronal networks in Alzheimer's disease. In both animal models of AD and in patients with mild cognitive impairment, Levetiracetam can offer benefit to cognition.
The investigators therefore aim to test whether Levetiracetam, through stabilisation of neuronal networks, may offer benefit to cognition in patients with AD.
Detailed description
Lay Summary:
Alzheimer's disease affects around 800,000 people in the UK alone and costs almost £23 billion per year. The only currently licensed treatments for Alzheimer's disease offer modest benefit at best. Seizures are more common in people with Alzheimer's disease and people with Alzheimer's disease may also have evidence of abnormal brainwave activity without having obvious seizures. Seizures may contribute to the loss of nerve cells and abnormal brainwave activity can disrupt thinking and memory. This abnormal electrical activity is therefore a potentially important drug target.
The anti-epileptic drug Levetiracetam can reduce abnormal brainwave activity and reverse memory deficits in a mouse model of Alzheimer's disease. Levetiracetam can also improve memory difficulties seen in people with mild cognitive impairment, a pre-cursor to Alzheimer's disease. Clinical use of Levetiracetam is already widespread and it is recommended by The National Institute of Health and Care Excellence as a first line treatment for seizures. Levetiracetam is generic (off-patent), is not known to interact with any other drugs and is well tolerated. A promising, cheap and safe approach might be to use Levetiracetam as a treatment to help with memory difficulties in Alzheimer's disease.
The proposed project is a proof of concept study. The investigators wish to allocate thirty patients with Alzheimer's disease with no history of previous seizure to initially receive either Levetiracetam or placebo before patients 'cross-over' so that the participants who initially received Levetiracetam are then given placebo and vice-versa. The effect that Levetiracetam has on memory in Alzheimer's disease will be studied using several standardised scales. Tests that the investigators have developed to better detect subtle improvements in thinking will also be used. Patients will have a straightforward, non-invasive test called an electroencephalogram to look at their brainwave activity at the start of the study, as there may be brainwave markers that might help to predict which patients would benefit most from Levetiracetam.
This study evaluates if an anti-epileptic medication can offer meaningful benefit to patients with Alzheimer's disease. If this study is successful, the next step will be to rapidly progress to a larger study to establish whether Levetiracetam may be a useful and cost-effective treatment for patients with Alzheimer's disease.
Main hypothesis:
- Treatment with the anti-epileptic drug Levetiracetam will be of benefit to cognitive deficits in Alzheimer's disease because electrophysiological disruption of neuronal networks contributes to the pathophysiology of the condition.
- Treatment with Levetiracetam at a dose that is routinely utilized in older people with epilepsy will be well tolerated in patients with Alzheimer's disease and, in particular, will not adversely affect mood
- Electroencephalography (EEG) may offer a biomarker to predict which patients with Alzheimer's disease might be especially suited to treatment with Levetiracetam
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Active treatment arm (Levetiracetam) | Experimental | Drug: LevetiracetamWhen in the active arm, after a baseline visit, participants will up-titrate Levetiracetam in 250mg steps at intervals of one week to Levetiracetam 500mg twice daily (two tablets twice daily). Participants will be maintained on Levetiracetam 500mg bd for four weeks and have a further full assessment at 8 weeks after being on Levetiracetam. Participants will then down-titrate Levetiracetam by 250mg every week until weaned to nil. |
| Control arm (placebo oral tablets) | Placebo comparator | Drug: Placebo Oral TabletWhen in the control arm, after a baseline visit, participants will up-titrate placebo (manufactured to look identical to Levetiracetam 250mg) in one tablet steps at intervals of one week to two tablets twice daily. Participants will be maintained on placebo for four weeks and have a further full assessment at 8 weeks after being on placebo. Participants will then down-titrate placebo by one tablet every week until weaned to nil. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female, 50 years or above.
- Diagnosed with mild to moderate AD (MMSE 10 to 26)
- Meets the National Institute of Aging-Alzheimer's Association criteria for probable AD (2011)
- Stable dose of current regular medication, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter. Acceptable forms of contraception include: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); total abdominal hysterectomy; barrier methods of contraception (condom or occlusive cap with spermicide); male sterilisation, if the vasectomised partner is the sole partner for the subject; true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception).
Key exclusion criteria (14 listed)
- Pre-existing diagnosis of epilepsy
- Clinical or laboratory evidence of a cause other than AD as a cause of their dementia
- Laboratory evidence of significant renal impairment (creatinine clearance <75 ml/minute) or liver dysfunction (liver function tests >2x upper limit of normal) within the preceding three months
- Visual or motor impairment that investigator deems severe enough to impair ability to complete computerised based touch screen task
- Use of anti-epileptic medication for any indication (epilepsy, pain or migraine) within previous three months
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 |
|---|---|---|
| LevetiracetamTo up-titrate Levetiracetam to 500mg (two tablets) twice daily followed by maintenance on Levetiracetam 500mg twice daily for four weeks and then down-titrate to nil over four weeks | Drug | Active treatment arm (Levetiracetam) |
| Placebo Oral TabletTo up-titrate placebo to two tablets twice daily followed by maintenance on placebo two tablets twice daily for four weeks and then down-titrate to nil over four weeks | Drug | Control arm (placebo oral tablets) |
Primary outcome
Effect of Levetiracetam on hippocampal function in patients with Alzheimer's disease as assessed by a computerised test of hippocampal binding
Time frame: 18 months
Change from baseline in measures of hippocampal binding on a standardised computer based test. Participants will be shown fractals on a screen, followed by a blank screen. The participants will be then shown one of the fractals they saw previously and a foil. The participants will have to identify which of the fractals they saw initially and then drag that fractal on the screen to the location where it appeared before. The computer will assess whether the participant correctly identifies which fractal had been seen previously and also assess how accurately the participant remembers the location of the previously shown fractal. The investigators will then evaluate whether there are any changes in the accuracy of remembering fractals/fractal position after exposure to Levetiracetam/placebo
5 secondary outcomes
Number of participants with treatment related serious adverse events as reported on the serious adverse events proforma
Time frame: 18 months
Effect of Levetiracetam on mood in patients with Alzheimer's disease
Time frame: 18 months
Effect of Levetiracetam on quality of life in patients with Alzheimer's disease as assessed by their principal carer
Time frame: 18 months
Effect of Levetiracetam on quality of life in patients with Alzheimer's disease
Time frame: 18 months
Determining role of the electroencephalogram in patients with Alzheimer's disease
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 34332638Sen A, Akinola M, Tai XY, Symmonds M, Davis Jones G, Mura S, Galloway J, Hallam A, Chan JYC, Koychev I, Butler C, Geddes J, Van Der Putt R, Thompson S, Manohar SG, Frangou E, Love S, McShane R, Husain M. An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a double-blind, placebo-controlled, randomised crossover proof of concept study. Trials. 2021 Jul 31;22(1):508. doi: 10.1186/s13063-021-05404-4.
- Derived from this study: PubMed 33973646Liu J, Wang LN. Treatment of epilepsy for people with Alzheimer's disease. Cochrane Database Syst Rev. 2021 May 11;5(5):CD011922. doi: 10.1002/14651858.CD011922.pub4.
- Individual participant dataSharing planned: Undecided. It is possible that irretrievably anonymised data will be shared with other researchers dependent on securing relevant ethical approval
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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.
Arjune Sen, PhD, FRCPE study director
Nuffield Department of Clinical Neurosciences
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 and Epilepsy, run by University of Oxford at 1 site in United Kingdom.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 24 Apr 2024. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Levetiracetam on hippocampal function in patients with Alzheimer's disease as assessed by a computerised test of hippocampal binding (time frame: 18 months). 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 NCT03489044, which also lists 2 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 24 Apr 2024.