RIVA-PSP

CompletedPhase 3

Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy

RIVA-PSP: Efficacy of Rivastigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy: A Randomised Double Blind Placebo-controlled Clinical Trial

Lead sponsor

Assistance Publique Hopitaux De Marseille

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

106

actual

Study population

Frontotemporal dementia

Key I/E criteria

•MMSE ≥20•Study partner/caregiver required

Primary endpoint

•Efficacy

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

Org study ID2015-11

Eudract number2016-001319-19

NCT IDNCT02839642

Timeline

Milestones

Study first posted2016-07-21estimated

Study start2016-07-26actual

Primary completion2022-06-03actual

Study completion2022-11-17actual

Last update posted2023-07-20actual

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age41 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Probable PSP of the Richardson subtype as defined by the NINDS-SPSP criteria modified so as to allow inclusions of patients who have first fallen within 3 years of disease onset.

•Aged 41 to 80 years at the time of screening

•Judged by site investigator to be able to comply with gait/balance and neuropsychological evaluations at baseline and throughout the study

•Able to ambulate independently or with assistance (cane)

•Score ≥ 20 on the mini-mental state examination (MMSE) at screening

•A reliable caregiver - defined as a person having frequent contact with subject (≥ 3 hours per day) and willing to fill the fall diaries and monitor study medication compliance and the subject's health and concomitant medication throughout the study - must accompany the subject to all visits.

•A fall or near fall rate ≥ 2/week in average (estimated through interview at screening and confirmed during a 2-week period between screening and baseline using fall postcards).

•Any parkinsonian medication taken by the subject must be stable in dose for 4 weeks prior to screening and must remain stable for the duration of the study

•Stable on all other chronic medications for 4 weeks prior to screening

•Written informed consent provided by subject and caregiver

Exclusion criteria

•Non ambulatory patient.

•History and clinical examination suggesting another parkinsonian syndrome (Parkinson's disease, Dementia with Lewy Bodies, Corticobasal Degeneration, Multisystem Atrophy, Vascular Parkinsonism, tumoral parkinsonism, anti-psychotic drug-induced parkinsonism)

•Presence of other significant neurological or psychiatric disorders: Alzheimer's disease, epilepsy, history of stroke, psychotic disorder, severe bipolar or unipolar disorder

•A fall or near fall rate < 2/week in average (during a 2-week period between screening and baseline using fall postcards).

•Insufficient fluency in local language to complete neuropsychological, global and gait/balance assessments

•Score < 20 on the mini-mental state examination at screening

•Within 4 weeks of screening or during the course of the study concurrent treatment with any cholinesterase inhibitor medication (donepezil, galantamine, rivastigmine) or any cholinergic agent (agonist or antagonist) including memantine.

•History of deep brain stimulation surgery.

•Within 4 weeks of screening or during the course of the study concurrent treatment with beta blockers, any antipsychotic drugs or mood stabilisers.

•Any malignancy within 5 years of screening or current significant - judged as such by the site investigator - hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease.

•Presence of an active gastro-duodenal ulcer, unstable asthma or chronic obstructive pulmonary disease.

•History of or current urinary retention requiring either anticholinergic medication or urethral catheterisation.

•The systolic blood pressure measurement is > 190 or < 85 mm Hg and/or the diastolic blood pressure measurement is > 105 or < 50 mm Hg at screening.

•Clinically significant laboratory abnormalities at screening, including creatinine ≥ 2.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of the normal reference range.

•The ECG is abnormal at screening and judged to be clinically significant by the site investigator. Particular attention will be given to any sign suggesting conduction disorders.

•Treatment with any investigational drugs or device within 60 days of screening.

•Ongoing pregnancy or lactation. Women with childbearing potential not using any form of efficacious contraception.

•Any contraindication for rivastigmine as defined by the ANSM

•Known hypersensitivity to rivastigmine or any cholinesterase inhibitor medication.

Endpoints (10)

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

Caregiver / quality of life

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Apathy assessed using the Lille Apathy Rating Scale (LARS) both subject and caregiver versions

Time frame:Baseline and 4 months

descriptive

Caregiver / quality of life

7 endpoints

Primary/protocol endpoint

Efficacy will be assessed at 4 months as the change from baseline of the number of falls and near falls over the past 2 week

Time frame:baseline, 2 weeks, 4 months

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at 4 months measured by the Clinical Global Impression scale (patient and caregiver)

Time frame:Baseline and 4 months

change from baseline, improvement

Secondary/protocol endpoint

Assessment of the Quality of life of patient using the PSP-Quality of Life Scale (PSP-QoL)

Time frame:Baseline and 4 months

descriptive

Secondary/protocol endpoint

Assessment of the Quality of life of patient using the EQ-5D

Time frame:Baseline and 4 months

descriptive

Secondary/protocol endpoint

Assessment of the Quality of life of the caregiver using the PSP-Quality of Life Scale (PSP-QoL)

Time frame:Baseline and 4 months

descriptive

Secondary/protocol endpoint

Assessment of the Quality of life of the caregiver using the EQ-5D

Time frame:Baseline and 4 months

descriptive

Secondary/protocol endpoint

Caregiver burden assessed using the Caregiver Reaction Assessement (CRA)

Time frame:Baseline and 4 months

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety: recording of adverse events at each study visit and at the phone calls

Time frame:4 months

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline at 4 months measured by the global ans sub scores of the PSPRS scale (Progressive Supranuclear Palsy Rating Scale)

Time frame:Baseline and 4 months

change from baseline, improvement

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.