← Trials/Trial dossier/NCT00417482

ADAD

CompletedPhase 4Results posted

Antipsychotic Discontinuation in Alzheimer's Disease

Lead sponsor

New York State Psychiatric Institute

Asset

Risperidone

Listed sites

Recruiting sites

Enrollment

180

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-26

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 ID#5598R

Nih5R01AG021488

NCT IDNCT00417482

Timeline

Milestones

Study start2004-08 (month precision)

Study first posted2007-01-01estimated

Primary completion2011-04actual (month precision)

Study completion2011-04actual (month precision)

Last update posted2013-04-24estimated

Results first posted2013-04-24estimated

Assets

Drug assets

Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Dementia, either sex, age 50-95 years

•Probable Alzheimer's disease

•Intellectual impairment present for at least 6 months

•Mini Mental State Exam (MMSE) score of 5-26 for outpatients and 2-26 for nursing home patients

•Availability of informant who has had direct contact with the patient for an average of at least once every week during the 3 months prior to study entry

•Meets Neuropsychiatric Inventory (NPI) criteria for either (1) psychosis, or (2) agitation/aggression

•Able to mobilize independently (if wheelchair-bound, the patient must be able to self-propel)

•Free of psychotropic medication (or able to tolerate washout) for at least 1 week prior to study entry. Low dose antidepressants and sedative/hypnotics allowed if they cannot be washed out and the dose remains stable for the study duration

•Expected to complete the study (including all efficacy evaluations) and be without major sensory impairment that would prevent participation in any aspect of the study

Exclusion criteria

•Current primary Axis I psychiatric disorder other than AD

•Substance abuse or dependence currently, or within the past year

•Dementia due to head trauma

•History of allergy to risperidone or intolerance to risperidone

•Diffuse Lewy body disease

•History of seizure disorder, infectious encephalitis, Parkinson's disease, central nervous system (CNS) neoplasm, tardive dyskinesia, stroke, transient ischemic attack (TIA) or uncontrolled atrial fibrillation

•Use of monoamine oxidase inhibitors (MAOIs) and unable to undergo 3-week washout; patients also may not take MAOIs for 2 weeks after completing the study

•In treatment with (a) depot antipsychotic within 2 weeks of the screening visit

•Untreated or incompletely treated hypothyroidism

•Active, unstable medical condition that requires active medication adjustment or surgery

•Need for electroconvulsive treatment (ECT)

•Significant risk for harm to themselves or others as a result of randomization to placebo

•History of malignant neoplasm during the last 5 years

Endpoints (16)

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

Other (unclassified)

Global cognition

Behavior / neuropsychiatric

Global cognition

2 endpoints

Secondary/protocol endpoint

Mini Mental State Exam (MMSE)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Mini Mental State Exam (MMSE)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Placebon=38 Participants	-0.13	1.49
Risperidonen=69 Participants	-0.77	2.23

Mean Difference (Final Values)0.6495% CI-0.08 - 1.35p0.08t-test, 2 sided

The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Relapse by Study Week 32

Time frame:0-16 weeks in Phase B (16-32 weeks in study)

Neuropsychiatric Inventory (NPI)

descriptive

Primary/registry result

Relapse by Study Week 32

Time frame:0-16 weeks in Phase B (16-32 weeks in study)

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (number), participants	Reported bounds
Phase B Arm 1: Risperidone-Risperidonen=32 Participants	15	-
Phase B Arm 2: Risperidone -Placebon=38 Participants	8	-
Phase B Arm 3: Placebo-Placebon=40 Participants	24	-

Hazard Ratio (HR)1.9495% CI1.09 - 3.45p0.02Stratified Cox analysis

Other (unclassified)

12 endpoints

Secondary/protocol endpoint/low confidence

Relapse by Study Week 48

Time frame:16-32 weeks in Phase B (32-48 weeks in study)

descriptive

Secondary/protocol endpoint/low confidence

Treatment Emergent Symptoms Scale (TESS)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Extrapyramidal Signs (EPS)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

AIMS

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Physical Self-Maintenance Scale (PSMS)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Weight

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Secondary/registry result/low confidence

Relapse by Study Week 48

Time frame:16-32 weeks in Phase B (32-48 weeks in study)

descriptive

Posted result

Group	Value (number), participants	Reported bounds
Arm 1: Risperidone - Risperidonen=13 Participants	2	-
Arm 2: Risperidone - Placebon=27 Participants	13	-

Hazard Ratio (HR)4.8895% CI1.08 - 21.98p0.02stratified cox analyses

Secondary/registry result/low confidence

Treatment Emergent Symptoms Scale (TESS)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Placebon=40 Participants	0.18	2.4
Risperidonen=70 Participants	0.21	2.5

Mean Difference (Final Values)-0.0495% CI-1.01 - 0.93p0.94t-test, 2 sided

The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.

Secondary/registry result/low confidence

Extrapyramidal Signs (EPS)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Placebon=40 Participants	-0.20	1.91
Risperidonen=70 Participants	0.34	2.68

Mean Difference (Final Values)-0.5495% CI-1.50 - 0.41p0.26t-test, 2 sided

The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.

Secondary/registry result/low confidence

AIMS

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Placebon=40 Participants	0.03	0.48
Risperidonen=70 Participants	0.24	1.01

Mean Difference (Final Values)-0.2295% CI-0.50 - 0.07p0.13t-test, 2 sided

The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.

Secondary/registry result/low confidence

Physical Self-Maintenance Scale (PSMS)

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Placebon=39 Participants	0.18	1.73
Risperidonen=70 Participants	0.80	2.72

Mean Difference (Final Values)-0.6295% CI-1.47 - 0.23p0.149t-test, 2 sided

The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.

Secondary/registry result/low confidence

Weight

Time frame:Phase B, weeks 1-16 (study weeks 16-32)

change from baseline, improvement

Posted result

Group	Value (mean), pounds	Standard deviation
Placebon=37 Participants	0.32	7.18
Risperidonen=64 Participants	0.73	8.71

Mean Difference (Final Values)-0.4195% CI-3.77 - 2.95p0.81t-test, 2 sided

The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.

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 tableClinicalTrials.gov results section

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.