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STREAM-VCI

UnknownPhase 2 / PHASE3

Symptomatic Treatment of Vascular Cognitive Impairment

Lead sponsor

Amsterdam UMC, location VUmc

Assets

Galantamine / Methylphenidate

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criterion

•MMSE ≥16

Primary endpoint

•Change on performance on executive function and on memory after active challenge

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02098824

Org study IDNL45933.029.13

Timeline

Milestones

Study start2014-02 (month precision)

Study first posted2014-03-28estimated

Last update posted2016-05-02estimated

Primary completion2016-12estimated (month precision)

Study completion2017-07estimated (month precision)

Assets

Drug assets

Galantamine Methylphenidate

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

•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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging

Memory

Safety / tolerability / PK

Other (unclassified)

Memory

2 endpoints

Primary/protocol endpoint

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

Time frame:timepoints 1 hour, 2.5 hours and 3.5 hours

descriptive

Secondary/protocol endpoint

Change on performance on other Neurocart tests after active challenge

Time frame:Timepoints 1.0 hour, 2.5 hours and 3.5 hours

descriptive

Neuroimaging

3 endpoints

Other/protocol endpoint

Locations and number of cerebrovascular lesions

Time frame:Single MRI scan after screening

event count, event

Other/protocol endpoint

Structural connectivity of white matter tracts

Time frame:Single MRI after screening

descriptive

Other/protocol endpoint

Functional connectivity in resting state networks

Time frame:Single MRI, after screening

descriptive

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Maximum concentration (Cmax)

Time frame:t-1.5, t=1, t=2.5, t=3.5

concentration, descriptive

Other/protocol endpoint

Time of Cmax (Tmax)

Time frame:t=-1.5, t=1, t=2.5, t=3.5

concentration, descriptive

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Area under the Curve

Time frame:t=-1.5, t=1, t=2.5,t=3.5

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.