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CompletedPhase 2

Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness

A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment

Asset

Botulinum Toxin

Listed sites

1

Recruiting sites

-

Enrollment

10

actual

Study population

Alzheimer’s disease, Frontotemporal dementia, Vascular cognitive impairment / dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoint

•Impact on care-giver burden

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 IDNCT02212119
Org study IDNT-036

Timeline

Milestones

Study start2010-12 (month precision)
Primary completion2013-02actual (month precision)
Study completion2014-01actual (month precision)
Study first posted2014-08-08estimated
Last update posted2014-08-08estimated

Assets

Drug assets

Botulinum Toxin

Study populations

Who this study enrolls

Alzheimer’s diseaseFrontotemporal dementiaVascular cognitive impairment / dementia

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Severe cognitive impairment (complete dependency in all activities of daily living (ADLs)
•Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia
•Score> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care

Exclusion criteria

•Alternate etiologies for increased tone
•Botulinum toxin 6 months preceding the study

Endpoints (5)

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
3
Executive function / language
1
Other (unclassified)
1

Executive function / language

1 endpoint
Secondary/protocol endpoint

Pain

Time frame:6 weeks for secondary outcome, 32 weeks for entire study

descriptive

Caregiver / quality of life

3 endpoints
Primary/protocol endpoint

Impact on care-giver burden

Time frame:6 weeks for primary outcome, 32 weeks for entire study

descriptive

Secondary/protocol endpoint

Visual Analogue Scale

Time frame:6 weeks for secondary outcome, 32 weeks for entire study

descriptive

Secondary/protocol endpoint

Global Assessment

Time frame:6 weeks for secondary outcome, 32 weeks for entire study

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Joint angle measurement

Time frame:6 weeks for secondary outcome, 32 weeks for entire study

descriptive

Publications (19)

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.