Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222527

Enrollment

880

Registered

2014-06-18

Start date

2014-06-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Interventions

investigational material(s) Generic name etc : Aripiprazole (2 mg) INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible). 2. Patients who satisfy both of the following diagnostic criteria: - Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to DSM-5 - Diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA 3. Hospitalized patients or care facility patients 4. Patients with an MMSE score of 1 to 22

Exclusion criteria

Exclusion criteria: 1. Patients with complications of dementia or memory impairment other than Alzheimer's type dementia 2. Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher 3. Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances 4. Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke 5. Patients with heart failure classified as NYHA III or IV 6. Patients who require drug therapy for arrhythmia or ischemic heart disease 7. Body weight of less than 30 kg 8. Patients with a high risk of suicide 9. Patients with a complication or history of seizure disorder 10. Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis 11. Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)

Design outcomes

Primary

Measure	Time frame
CMAI Change from baseline	—

Secondary

Measure	Time frame
CGI-S/I Change from baseline(CGI-S), score after 10 weeks(CGI-I)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026