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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.

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

Toyama Ikuo

Shiga University of Medical Science

Seta-Tsukinowa-cho, Otsu City, 520-2192, Shiga Japan

clindev_ntpi@nippon-zoki.co.jp

Kusunoki Shinsuke

Nippon Zoki Pharmaceutical Co. , Ltd.

2-3, Hiranomachi, 4-chome, Chuo-ku, Osaka

+81-6-6203-0455

clindev_ntpi@nippon-zoki.co.jp

Not Recruiting

Sept. 13, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

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.

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.

Both

Japanese patients with behavioral and psychological symptoms associated with Alzheimer's disease

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 ampoules of NTPI

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

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

+81-92-725-7900

Aug. 16, 2022

No

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