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Mild Cognitive Impairment (Vascular)Phase 2/3STREAM-VCINCT02098824

Symptomatic Treatment of Vascular Cognitive Impairment

A Phase 2/3 study testing Galantamine and Methylphenidate in people with Mild Cognitive Impairment (Vascular) and Mild Cognitive Disorder (Vascular), run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Single center threeway double blind cross over trial investigating the pharmacological responsivity in patients with VCI using a challenge aimed at the monoaminergic and cholinergic neuronal systems Read more about this study

Who is it for?
Any age
What is being tested?
Galantamine and Methylphenidate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteNetherlands
Study dates
Feb 2014to Jul 2017
Phase
Phase 2/3
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

  • Outpatients
  • Objective executive dysfunction and/or memory impairment on neuropsychological tests and imaging evidence of cerebrovascular disease (white matter changes (Fazekas ≥2, (lacunar) infarcts)
  • Mini Mental State Examination (MMSE) ≥16
  • Clinical Dementia Rating Score (CDR of 0.5-1)
  • No contraindication for treatment with a Cholinesterase inhibitor (CEI) or Methylphenidate (MPH) (www.fk.cvz.nl)
  • Assessed by the treating neurologist as mentally capable of understanding the implications of study participation
  • Presence of an informant/caregiver at the information visit, signing of informed consent, and all study visits

Who cannot join

  • Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history taking and physical examinations obtained during the screening visit and/or at the study day as judged by the investigator;
  • Clinically relevant abnormal laboratory results, electrocardiogram (ECG) and vital signs, or physical findings at screening and/or at the start of the study day (as judged by the investigator);
  • Unwilling to or unable to stop smoking on the study day until the end of the study day
  • Other causes that can explain cognitive symptoms including but not limited to: delirium, multiple sclerosis, amyotrophic lateral sclerosis, progressive supranuclear palsy, mental retardation, infectious encephalitis that led to persistent cognitive deficits or head trauma with loss of consciousness that led to persistent cognitive deficits
  • Use of neuroleptics
  • Use of celiprolol or sotalol
Show all 15Show fewer
  • Use of MAO-A/B inhibitors
  • Current use of centrally acting anticholinergics (e.g. oxybutynin, mebeverine, ipratropium(bromide))
  • Use of benzodiazepine within 48 hours before a study day
  • Current use of a CEI (rivastigmine, galantamine, donepezil)
  • Alcohol abuse (defined as use of alcohol despite significant areas of dysfunction, evidence of physical dependence, and/or related hardship due to alcohol)
  • Use of recreational drugs
  • Concomitant use of inhibitors of CYP2D6 (a/o kinidine, paroxetine, fluoxetine) or of CYP3A4 (a/o ketoconazole, ritonavir); unless patients are on a stable dose without any recent or upcoming changes
  • Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
  • Any contra-indication for MRI

Trial locations and contacts

1 site in 1 country.

Niels D Prins, MD,PhD contact

+20 3017170

nd.prins@vumc.nl

Jolien F Leijenaar, MD, MSc contact

+204440183

j.leijenaar@vumc.nl

Netherlands1 site, 1 recruiting

  • VU University Medical Center

    Amsterdam, 1081 HV

    Niels D Prins, MD, PhD, +20 3017170, nd.prins@vumc.nl

    Jolien F Leijenaar, MD, MSc

    Recruiting

Other trials in Netherlands

About this study

Single center threeway double blind cross over trial investigating the pharmacological responsivity in patients with VCI using a challenge aimed at the monoaminergic and cholinergic neuronal systems

Read the detailed description

Vascular Cognitive Impairment is an important cause of cognitive impairment and dementia. Till now, there are no approved symptomatic treatments for Vascular Cognitive Impairment. Research on novel pharmacological treatments that may reduce clinical symptoms in these patients is needed. Evidence suggests that executive dysfunction and memory impairment in Vascular Cognitive Impairment are caused by damage to monoaminergic and cholinergic neurotransmitter-systems, respectively.

However, patients with Vascular Cognitive Impairment form a clinically heterogeneous group, i.e. the extent to which executive function and memory are affected differs from patient to patient. Previous intervention studies have not taken this inter-patient variability into account. Individually tailored pharmacological interventions, aimed at the affected neurotransmitter systems, may ameliorate cognitive symptoms in patients with Vascular Cognitive Impairment. Using a pharmacological challenge, it is possible to detect individual sensitivity to specific pharmacological interventions. Furthermore, with the use of novel MRI techniques, it is possible to correlate the location and severity of cerebrovascular lesions to impaired structural and functional connectivity in each subject.

The investigators will recruit 30 patients with Vascular Cognitive Impairment (according to the criteria of the American Heart Association/American Stroke Association), at the Alzheimer Center of the VU University Medical Center and the Utrecht University Medical Center. They will also undergo MRI, including diffusion tensor imaging MRI (DTI)/'fiber tracking'; and resting state (RS) functional MRI (fMRI). In a double-blind, three-way, case cross over trial, the investigators will study the effects of methylphenidate on executive function and of galantamine on episodic memory function. During three separate visits, patients will receive the pharmacological interventions (placebo, methylphenidate, and galantamine) at the investigators Clinical Research Unit. Also, during a study day the investigators will collect blood samples at different timepoints.

Being tested
Galantamine, Methylphenidate, Placebo
Keywords
vascular cognitive impairment, treatment, cerebrovascular lesions, memory impairment, executive dysfunction, neuronal networks, white matter tracts, monoaminergic systems, cholinergic systems, DTI, rs-fMRI
Medical subject headings
Cognitive Dysfunction, Neurocognitive Disorders, Dementia, Vascular, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalantamineDrug

    Also called Reminyl

    Single administration of capsule containing 16 mg of Galantamine

  • MethylphenidateDrug

    Also called Ritalin

    Single administration of capsule containing 10 mg of Methylphenidate

  • PlaceboDrug

    Single administration of capsule containing placebo

Study groups in NCT02098824
Study groupRoleWhat they receive
GalantamineActive comparatorSingle administration of capsule containing 16 mg Galantamine
Receives: Drug: Galantamine
PlaceboPlacebo comparatorSingle oral administration of capsule containing placebo
Receives: Drug: Placebo
MethylphenidateActive comparatorSingle administration of capsule containing 10 mg Methylphenidate
Receives: Drug: Methylphenidate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change on performance on executive function and on memory after active challenge

    Patients will perform multiple Neurocart tests: eye movement recording, pharmaco-EEG's, visual verbal language test (VVLT), Adaptive Tracker, Facial Recognition taks, N-back and Stop Signal test of which the Adaptive Tracker and VVLT have the main focus.

    Measured: timepoints 1 hour, 2.5 hours and 3.5 hours

Secondary outcomes (1)

  1. Change on performance on other Neurocart tests after active challenge

    Change of performance on the other tests: N-back, Facial recognition task, Stop Signal task, eye movements and pharmaco-EEG

    Measured: Timepoints 1.0 hour, 2.5 hours and 3.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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 2/3
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02098824
Sponsor's protocol ID
NL45933.029.13
Acronym
STREAM-VCI
Status last verified
Apr 2016
First submitted
14 Mar 2014
Last updated
2 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Leijenaar JF, Groeneveld GJ, Klaassen ES, Leeuwis AE, Scheltens P, Weinstein HC, van Gerven JMA, Barkhof F, van der Flier WM, Prins ND. Methylphenidate and galantamine in patients with vascular cognitive impairment-the proof-of-principle study STREAM-VCI. Alzheimers Res Ther. 2020 Jan 7;12(1):10. doi: 10.1186/s13195-019-0567-z.

    PubMed 31910895

  • Leijenaar JF, Groeneveld GJ, van der Flier WM, Scheltens P, Klaassen ES, Weinstein HC, Biessels GJ, Barkhof F, Prins ND. Symptomatic Treatment of Vascular Cognitive Impairment (STREAM-VCI): Protocol for a Cross-Over Trial. JMIR Res Protoc. 2018 Mar 20;7(3):e80. doi: 10.2196/resprot.9192.

    PubMed 29559423

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Galantamine and Methylphenidate in people with Mild Cognitive Impairment (Vascular) and Mild Cognitive Disorder (Vascular), run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

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 7 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 May 2016. 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 Netherlands. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Niels D Prins, MD,PhD (+20 3017170, nd.prins@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on performance on executive function and on memory after active challenge (time frame: timepoints 1 hour, 2.5 hours and 3.5 hours). 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 NCT02098824, 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 2 May 2016.

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