Dementia, VascularPhase 2PASTISNCT02450253
Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial
A Phase 2 study testing Tadalafil, Cognitive functioning tests and Neuropsychological tests in people with Dementia, Vascular, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive function in patients with cerebral small vessel disease Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia, Vascular
- What is being tested?
- Tadalafil, Cognitive functioning tests and Neuropsychological tests
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 25 Jan 2018
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Radiological evidence of cerebral small vessel disease defined as: MRI evidence of lacunar infarct(s) (≤ 1.5 cm maximum diameter) and/or confluent deep white matter leukoaraiosis (≥ grade 2 on Fazekas scale)
- 2. Clinical evidence of cerebral small vessel disease can be:
- lacunar stroke syndrome with symptoms lasting >24 hours, occurring at least 6 months previously; OR:
- transient ischaemic attack lasting < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 6 months previously AND with MRI DWI performed acutely showing lacunar infarction, OR if MRI is not performed within 10 days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI
- 3. Age ≥ 55 years.
- 4. Imaging of the carotid arteries with Doppler ultrasound, CT angiography or MR angiography in the previous 12 months, demonstrating < 70% stenosis in both internal carotid arteries
Who cannot join
- Known diagnosis of dementia
- Cortical infarction (>1.5 cm maximum diameter)
- Systolic BP <90 and/or diastolic BP < 50
- Creatinine Clearance<50ml/min
- Severe hepatic impairment
- History of Lactose intolerance
Show all 20Show fewer
- Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, vardenafil.
- Concomitant use of alpha-blockers e.g. alfuzosin, doxazosin, indoramin, prazosin, tamsulosin, and terazosin can all increase the risk of postural hypotension.
- Participants receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
- weight > 130kg
- 11 Uncontrolled cardiac failure
- 12. Persistent or paroxysmal atrial fibrillation
- 13. History of gastric ulceration
- 14. History of 'sick sinus syndrome' or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block
- 15. Uncontrolled COPD
- 16. Stroke or TIA within the last 6 months
- 17. MRI not tolerated or contra-indicated : MRI exclusion criteria -Participant has a cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury; possibility of pregnancy
- 18. Known monogenic causes of stroke e.g.. CADASIL
- 19 Unable to provide informed consent
- 20. enrolled in another CTIMP study
Trial locations and contacts
1 site in 1 country.
About this study
Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive function in patients with cerebral small vessel disease
Read the detailed description
Cerebral small vessel disease (SVD) is the primary cause of vascular cognitive impairment (VCI), which in its most severe form manifests as vascular dementia (VaD). SVD is a fibrous thickening of small penetrating arteries in deep brain nuclei (basal ganglia, thalami) and subcortical white matter.Clinical studies suggest that pure VCI/VaD contributes approximately 8-15% of dementia in older people Reduced CBF is well established in VCI. Improved blood flow in the vasculature of the deep white and grey matter is therefore an attractive mechanism for slowing the pathology of VCI and is a valuable biomarker for an initial proof of concept study.
To increase the likelihood of success in a full scale clinical trial of tadalafil in VCI, this study will test the effects of single dose tadalafil on cerebral blood flow in subjects with SVD using ASL-MRI. A strict definition of SVD will be used that combines clinical and MRI criteria.
Phosphodiesterase-5 (PDE5) specifically degrades cGMP within cells; limiting activation of protein kinase G. Guanylyl cyclase enzymes generate cGMP, downstream from NOS-nitric oxide signalling.
PDE5 inhibitors in SVD. PDE5 blockade is a plausible strategy to improve local cerebral blood flow (CBF), in the deep brain areas afflicted by SVD. By augmenting the NO-cGMP-PKG pathway, PDE5i drugs are expected to be vaso-relaxant in small artery myocytes.
In patients with pulmonary hypertension sildenafil improved cerebral vascular reactivity in response to hypercapnic challenge, indicative of an improvement in neurovascular coupling. Similar increased reactivity was recorded 60 min after administration of sildenafil in ED patients. By contrast, healthy volunteers showed no change in MCA blood flow following sildenafil, similar to healthy rodents, where vasodilation occurred only at high concentrations of drug. Overall it appears that PDE5i may have little effect on "healthy" cerebral arteries in rodents and humans.
Prior human studies have been single dose studies of PDE5i in healthy humans, have only used sildenafil and have in general estimated CBF from Middle Cerebral Artery (MCA) blood flow using Trans Cranial Doppler (TCD). MCA blood flow may not reflect local blood flow in the microvasculature of the deep white and deep grey matter. One study examined the effect of single dose sildenafil on CBF using SPECT in patients with vascular risk factors with or without a history of stroke. Non-stroke patients exhibited an overall increase in CBF. However, no distinction was made in this study between large vessel and lacunar stroke.
In summary, pre-clinical studies support a CBF-enhancing action of PDE5i in cerebrovascular disease, while human studies to date have been limited to sildenafil and have not specifically addressed effects on CBF in people with SVD.
Tadalafil (Cialis®) is widely-used as an oral agent for sexual dysfunction. As an inhibitor of the enzyme PDE5, tadalafil has a well-established pharmacological profile as a small vessel vasodilator. Side-effect profile and pharmacokinetics are well known and the drug is well-tolerated in the target population, over a range of oral doses and regimens. The choice of tadalafil over other PDE5 inhibitors (such as sildenafil, Viagra®) is based on potency, selectivity for PDE5, plasma half-life and documented brain penetration.
Phosphodiesterase-5 (PDE5) specifically degrades cGMP within cells; limiting activation of protein kinase G. Guanylyl cyclase enzymes generate cGMP, downstream from NOS-nitric oxide signalling. The PDE5 inhibitor sildenafil (Viagra®; discovered at Pfizer, Sandwich UK) raised the profile of PDE5 as a therapeutic target. Tadalafil (Cialis®; licence holder: Eli Lilly) is widely prescribed on an "as required" basis for ED in men. It is also licensed for regular daily use at a dose of 5 mg for benign prostatic hyperplasia and 40 mg for pulmonary hypertension. Tadalafil is well tolerated and its side effect profile is well-established
- Conditions
- Dementia, Vascular
- Being tested
- Tadalafil, Placebo, Cognitive functioning tests, Neuropsychological tests, MRI Scan - Arterial Spin Labelling
- Keywords
- Vascular cognitive impairment
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called Cialis
single dose, 20 mg capsule p.o.
PlaceboDrug
single dose, matching capsule p.o.
Cognitive functioning testsBehavioural
Also called TOPF, NIHSS, MoCA,
Cognitive function tests will be performed prior to MRI scan 1 performed prior to IMP dosing on 2 occasions as patient will act as their own control
Neuropsychological testsBehavioural
Also called CANTAB, BMIPB, RBANS subtest
Neuropsychological tests will be performed prior to pre IMP dose MRI scan \& then parallel V2 of the tests repeated 3-5 post IMP dose and before 2nd MRI scan.
Participants act as own controls as 1 IMP occasion will be placebo- 2nd IMP occasion will be active. 7-30 days apart
MRI Scan - Arterial Spin LabellingOther
Pre and post IMP dose on 2 occasions to detect difference in blood flow in deep brain 4 MRI scans in total
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Tadalafil 20mg Capsule Stat single dose 2 x MRI scans (pre and post dose) Neuropsychological tests pre and post IMP dose Cognitive functioning prior to 1st MRI scan of that visit Receives: Drug: Tadalafil; Behavioral: Cognitive functioning tests; Behavioral: Neuropsychological tests; Other: MRI Scan - Arterial Spin Labelling |
| Control | Placebo comparator | Matched placebo Capsule Stat single dose 2 x MRI scans (pre and post dose) Neuropsychological tests pre and post IMP dose Cognitive functioning prior to 1st MRI scan of that visit Receives: Drug: Placebo; Behavioral: Cognitive functioning tests; Behavioral: Neuropsychological tests; Other: MRI Scan - Arterial Spin Labelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in deep brain blood flow as measured by MRI-Arterial Spin Labelling
Measured: 3-5 hours following IMP dosing
Secondary outcomes (1)
Change in regional CBF in cortical grey matter areas Plasma [drug concentration] dependence of deep CBF as measured by MRI ASL Changes in neuropsychological parameters including attention in Neuro attention and cognitive speed
Measured: 3-5 hours following IMP dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startSep 2015
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
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 Dementia, VascularStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Alzheimer's Society, University of Copenhagen, University of Glasgow, St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jeremy Dr Isaacs, MRCP PhD, Principal investigator, St George's University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450253
- Sponsor's protocol ID
- 14.0189
- Other IDs
- 2015-001235-20, 15/LO/0714, 20140901, 2015
- Acronym
- PASTIS
- Status last verified
- Aug 2018
- First submitted
- 18 May 2015
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Pauls MMH, Binnie LR, Benjamin P, Betteridge S, Clarke B, Dhillon MK, Ghatala R, Hainsworth FAH, Howe FA, Khan U, Kruuse C, Madigan JB, Moynihan B, Patel B, Pereira AC, Rostrup E, Shtaya ABY, Spilling CA, Trippier S, Williams R, Young R, Barrick TR, Isaacs JD, Hainsworth AH. The PASTIS trial: Testing tadalafil for possible use in vascular cognitive impairment. Alzheimers Dement. 2022 Dec;18(12):2393-2402. doi: 10.1002/alz.12559. Epub 2022 Feb 8.
PubMed 35135037Binnie LR, Pauls MMH, Benjamin P, Dhillon MK, Betteridge S, Clarke B, Ghatala R, Hainsworth FAH, Howe FA, Khan U, Kruuse C, Madigan JB, Moynihan B, Patel B, Pereira AC, Rostrup E, Shtaya ABY, Spilling CA, Trippier S, Williams R, Isaacs JD, Barrick TR, Hainsworth AH. Test-retest reliability of arterial spin labelling for cerebral blood flow in older adults with small vessel disease. Transl Stroke Res. 2022 Aug;13(4):583-594. doi: 10.1007/s12975-021-00983-5. Epub 2022 Jan 26.
PubMed 35080734
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial
- ClinicalTrials.gov ID
- NCT02450253
- Acronym / sponsor ID
- PASTIS / 14.0189
- Conditions
- Dementia, Vascular
- Keywords
- Vascular cognitive impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Alzheimer's Society, University of Copenhagen, University of Glasgow, St George's University Hospitals NHS Foundation Trust
- Study start
- Sep 2015
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 21 May 2015 (estimated)
- 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.
Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive function in patients with cerebral small vessel disease
Detailed description
Cerebral small vessel disease (SVD) is the primary cause of vascular cognitive impairment (VCI), which in its most severe form manifests as vascular dementia (VaD). SVD is a fibrous thickening of small penetrating arteries in deep brain nuclei (basal ganglia, thalami) and subcortical white matter.Clinical studies suggest that pure VCI/VaD contributes approximately 8-15% of dementia in older people Reduced CBF is well established in VCI. Improved blood flow in the vasculature of the deep white and grey matter is therefore an attractive mechanism for slowing the pathology of VCI and is a valuable biomarker for an initial proof of concept study.
To increase the likelihood of success in a full scale clinical trial of tadalafil in VCI, this study will test the effects of single dose tadalafil on cerebral blood flow in subjects with SVD using ASL-MRI. A strict definition of SVD will be used that combines clinical and MRI criteria.
Phosphodiesterase-5 (PDE5) specifically degrades cGMP within cells; limiting activation of protein kinase G. Guanylyl cyclase enzymes generate cGMP, downstream from NOS-nitric oxide signalling.
PDE5 inhibitors in SVD. PDE5 blockade is a plausible strategy to improve local cerebral blood flow (CBF), in the deep brain areas afflicted by SVD. By augmenting the NO-cGMP-PKG pathway, PDE5i drugs are expected to be vaso-relaxant in small artery myocytes.
In patients with pulmonary hypertension sildenafil improved cerebral vascular reactivity in response to hypercapnic challenge, indicative of an improvement in neurovascular coupling. Similar increased reactivity was recorded 60 min after administration of sildenafil in ED patients. By contrast, healthy volunteers showed no change in MCA blood flow following sildenafil, similar to healthy rodents, where vasodilation occurred only at high concentrations of drug. Overall it appears that PDE5i may have little effect on "healthy" cerebral arteries in rodents and humans.
Prior human studies have been single dose studies of PDE5i in healthy humans, have only used sildenafil and have in general estimated CBF from Middle Cerebral Artery (MCA) blood flow using Trans Cranial Doppler (TCD). MCA blood flow may not reflect local blood flow in the microvasculature of the deep white and deep grey matter. One study examined the effect of single dose sildenafil on CBF using SPECT in patients with vascular risk factors with or without a history of stroke. Non-stroke patients exhibited an overall increase in CBF. However, no distinction was made in this study between large vessel and lacunar stroke.
In summary, pre-clinical studies support a CBF-enhancing action of PDE5i in cerebrovascular disease, while human studies to date have been limited to sildenafil and have not specifically addressed effects on CBF in people with SVD.
Tadalafil (Cialis®) is widely-used as an oral agent for sexual dysfunction. As an inhibitor of the enzyme PDE5, tadalafil has a well-established pharmacological profile as a small vessel vasodilator. Side-effect profile and pharmacokinetics are well known and the drug is well-tolerated in the target population, over a range of oral doses and regimens. The choice of tadalafil over other PDE5 inhibitors (such as sildenafil, Viagra®) is based on potency, selectivity for PDE5, plasma half-life and documented brain penetration.
Phosphodiesterase-5 (PDE5) specifically degrades cGMP within cells; limiting activation of protein kinase G. Guanylyl cyclase enzymes generate cGMP, downstream from NOS-nitric oxide signalling. The PDE5 inhibitor sildenafil (Viagra®; discovered at Pfizer, Sandwich UK) raised the profile of PDE5 as a therapeutic target. Tadalafil (Cialis®; licence holder: Eli Lilly) is widely prescribed on an "as required" basis for ED in men. It is also licensed for regular daily use at a dose of 5 mg for benign prostatic hyperplasia and 40 mg for pulmonary hypertension. Tadalafil is well tolerated and its side effect profile is well-established
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Drug: Tadalafil, Behavioral: Cognitive functioning tests, Behavioral: Neuropsychological tests, Other: MRI Scan - Arterial Spin LabellingTadalafil 20mg Capsule Stat single dose 2 x MRI scans (pre and post dose) Neuropsychological tests pre and post IMP dose Cognitive functioning prior to 1st MRI scan of that visit |
| Control | Placebo comparator | Drug: Placebo, Behavioral: Cognitive functioning tests, Behavioral: Neuropsychological tests, Other: MRI Scan - Arterial Spin LabellingMatched placebo Capsule Stat single dose 2 x MRI scans (pre and post dose) Neuropsychological tests pre and post IMP dose Cognitive functioning prior to 1st MRI scan of that visit |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Radiological evidence of cerebral small vessel disease defined as: MRI evidence of lacunar infarct(s) (≤ 1.5 cm maximum diameter) and/or confluent deep white matter leukoaraiosis (≥ grade 2 on Fazekas scale)
- lacunar stroke syndrome with symptoms lasting >24 hours, occurring at least 6 months previously; OR:
- transient ischaemic attack lasting < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 6 months previously AND with MRI DWI performed acutely showing lacunar infarction, OR if MRI is not performed within 10 days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI
- 3. Age ≥ 55 years.
- 4. Imaging of the carotid arteries with Doppler ultrasound, CT angiography or MR angiography in the previous 12 months, demonstrating < 70% stenosis in both internal carotid arteries
Key exclusion criteria (20 listed)
- 11 Uncontrolled cardiac failure
- 12. Persistent or paroxysmal atrial fibrillation
- 13. History of gastric ulceration
- 14. History of 'sick sinus syndrome' or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block
- 15. Uncontrolled COPD
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 |
|---|---|---|
| TadalafilAlso: Cialissingle dose, 20 mg capsule p.o. | Drug | Active Treatment |
| Placebosingle dose, matching capsule p.o. | Drug | Control |
| Cognitive functioning testsAlso: TOPF, NIHSS, MoCA,Cognitive function tests will be performed prior to MRI scan 1 performed prior to IMP dosing on 2 occasions as patient will act as their own control | Behavioural | Active Treatment, Control |
| Neuropsychological testsAlso: CANTAB, BMIPB, RBANS subtestNeuropsychological tests will be performed prior to pre IMP dose MRI scan \& then parallel V2 of the tests repeated 3-5 post IMP dose and before 2nd MRI scan. Participants act as own controls as 1 IMP occasion will be placebo- 2nd IMP occasion will be active. 7-30 days apart | Behavioural | Active Treatment, Control |
| MRI Scan - Arterial Spin LabellingPre and post IMP dose on 2 occasions to detect difference in blood flow in deep brain 4 MRI scans in total | Other | Active Treatment, Control |
Primary outcome
change in deep brain blood flow as measured by MRI-Arterial Spin Labelling
Time frame: 3-5 hours following IMP dosing
1 secondary outcome
Change in regional CBF in cortical grey matter areas Plasma [drug concentration] dependence of deep CBF as measured by MRI ASL Changes in neuropsychological parameters including attention in Neuro attention and cognitive speed
Time frame: 3-5 hours following IMP dosing
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 27 Oct 2022.
- Derived from this study: PubMed 35135037Pauls MMH, Binnie LR, Benjamin P, Betteridge S, Clarke B, Dhillon MK, Ghatala R, Hainsworth FAH, Howe FA, Khan U, Kruuse C, Madigan JB, Moynihan B, Patel B, Pereira AC, Rostrup E, Shtaya ABY, Spilling CA, Trippier S, Williams R, Young R, Barrick TR, Isaacs JD, Hainsworth AH. The PASTIS trial: Testing tadalafil for possible use in vascular cognitive impairment. Alzheimers Dement. 2022 Dec;18(12):2393-2402. doi: 10.1002/alz.12559. Epub 2022 Feb 8.
- Derived from this study: PubMed 35080734Binnie LR, Pauls MMH, Benjamin P, Dhillon MK, Betteridge S, Clarke B, Ghatala R, Hainsworth FAH, Howe FA, Khan U, Kruuse C, Madigan JB, Moynihan B, Patel B, Pereira AC, Rostrup E, Shtaya ABY, Spilling CA, Trippier S, Williams R, Isaacs JD, Barrick TR, Hainsworth AH. Test-retest reliability of arterial spin labelling for cerebral blood flow in older adults with small vessel disease. Transl Stroke Res. 2022 Aug;13(4):583-594. doi: 10.1007/s12975-021-00983-5. Epub 2022 Jan 26.
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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.
Jeremy Dr Isaacs, MRCP PhD principal investigator
St George's University Hospitals NHS Foundation Trust
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 Tadalafil, Cognitive functioning tests and Neuropsychological tests in people with Dementia, Vascular, run by St George's, University of London 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 6 inclusion and 20 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 27 Oct 2022. 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?
change in deep brain blood flow as measured by MRI-Arterial Spin Labelling (time frame: 3-5 hours following IMP dosing). 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 NCT02450253, 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 27 Oct 2022.