A Phase II Study of NTPI in Patients with Behavioral and Psychological Symptoms Associated with Alzheimer's Disease.

A Phase II Multi-Center, Placebo-Controlled, Randomized, Double Blind, Parallel Group Study of NTPI in Patients with Behavioral and Psychological Symptoms Associated with Alzheimer's Disease.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220042

Enrollment

Registered

2022-08-26

Start date

2022-10-05

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

Japanese patients with behavioral and psychological symptoms associated with Alzheimers disease

Interventions

Administered intravenously, three times a week for 12 weeks. NTPI plasebo group : 10 ampoules of plasebo NTPI 18.0 NU group : 5 ampoules of plasebo and 5 ampoules of NTPI NTPI 36.0 NU group : 10 a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have received sufficient explanation about this clinical trial, and obtained written consent of their agent and themselves. 2) Patients aged between 65 and 85 at the time of consent acquisition. 3) Patients fulfilled the criteria for "Probable AD dementia" of the NIA-AA diagnostic guidelines for Alzheimer's disease. 4) Patients with baseline MMSE score ranged from 10 to 20. 5) Patients with baseline NPI total score of 20 or more. 6) Patients judged to require drug therapy for behavioral and psychological symptoms associated with Alzheimer's disease.

Exclusion criteria

Exclusion criteria: 1) Patients with dementia other than Alzheimer's disease. 2) Patients with behavioral and psychological symptoms induced by other diseases or drug. 3) Patients with alcohol or drug dependency, or having a medical history of them. 4) Patients with convulsive and/or epileptic seizure, or having a medical history of them. 5) Patients with thyroid disease. 6) Patients treated antipsychotics or psychostimulants for behavioral and psychological symptoms associated with Alzheimer's disease within 1 month before the day of consent acquisition. 7) Patients treated any therapy such as electroconvulsive therapy, high-intensity phototherapy or transcranial magnetic stimulation, within 3 months before the day of consent acquisition.

Design outcomes

Primary

Measure	Time frame
Amount of change from baseline in the sum of products multiplied NPI frequency and severity scores during 12-week treatment.	—

Secondary

Measure	Time frame
Amount of change from baseline in the following outcomes during 12-week treatment (1) NPI products multiplied frequency and severity scores for individual neuropsychiatric disturbances (2) total caregiver distress score (3) individual caregiver distress scores (4) walking velocity (5) grip strength (6) body weight (7) EQ-5D-5L Proxy score (8) ADCS-ADL-severe score (9) MMSE score	—

Contacts

Public ContactShinsuke Kusunoki

Nippon Zoki Pharmaceutical Co. , Ltd.

clindev_ntpi@nippon-zoki.co.jp+81-6-6203-0455

Outcome results

None listed

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