NCT04341467

Brief Summary

Currently, olanzapine is the most widely used and studied drug for the treatment of behavioral and psychological symptoms in patients with Alzheimer's disease, but there are significant side effects. Amisulpride is a new antipsychotic that not only controls mental symptoms but also improves cognitive function. Therefore, the aim of this study was to evaluate the effectiveness and tolerability of both amisulpride and Olanzapine for treating the behavioral and psychological symptoms of dementia in patients with dementia of the Alzheimer type.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 16, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

December 27, 2019

Last Update Submit

November 15, 2022

Conditions

BPSDAmisulprideOlanzapineDementia of the Alzheimer Type

Outcome Measures

Primary Outcomes (1)

  • Changes of neuropsychiatric inventory（NPI）scores

    The change from baseline neuropsychiatric inventory (NPI) items at week 2,4,and 8. Assess the frequency and severity of psychiatric symptoms, including delusions, hallucinations, aggression attacks, depression, anxiety, elevated emotions, indifferent emotions, de-inhibition, agitation, abnormal behaviors, sleep / night behaviors, appetite / eating disorders,the maximum scores is 144.The higher score are considered the psychiatric symptoms more serious.

    baseline, Week 2,4, and 8

Secondary Outcomes (7)

  • Changes of Clinical global impression-Severity of Illness (CGI-SI) score

    baseline, Week 2,4, and 8

  • Changes of Clinical global impression- global improvement (CGI-GI)

    baseline, Week 2,4, and 8

  • Changes of Mini-Mental State Examination(MMSE) scores.

    baseline, Week 2,4, and 8

  • Changes of Caregiver Burden Inventory (CBI) scores

    baseline, Week 2,4, and 8

  • Treatment Emergent Symptom Scale (TESS)

    Week 2,4, and 8

  • +2 more secondary outcomes

Study Arms (2)

Amisulpride group

EXPERIMENTAL

The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.

Drug: Amisulpride

Olanzapine group

ACTIVE COMPARATOR

The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.

Drug: Olanzapine

Interventions

AmisulprideDRUG

The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.

Also known as: Solian
Amisulpride group
OlanzapineDRUG

The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.

Also known as: Oulanning
Olanzapine group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • It conforms to the diagnostic standard of Alzheimer's disease in International Classification of Diseases 10th Revision (ICD-10)
  • a total score of MMSE\<24
  • The patients had active behavioral symptoms with a minimum score of 20 on the 12-point Neuropsychiatric Inventory (NPI)
  • Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised

You may not qualify if:

  • People with vascular dementia, frontotemporal dementia, dementia with Lewy bodies or other neurocognitive disorders;
  • Patients with severe brain organic diseases or brain trauma;
  • Physical illnesses associated with severe respiratory, circulatory, immune, and endocrine systems;
  • History of other mental disorders;
  • Those who are allergic to amisulpride or olanzapine;
  • Patients who are contraindicated with amisulpride and olanzapine: pheochromocytoma, prolactin-dependent tumors and narrow-angle glaucoma;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

MeSH Terms

Interventions

AmisulprideOlanzapine

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Jie Li, Doctor

CONTACT

022-88188006tjlijie3827@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2019

First Posted

April 10, 2020

Study Start

December 1, 2019

Primary Completion

December 1, 2023

Study Completion

May 1, 2024

Last Updated

November 16, 2022

Record last verified: 2022-10

Locations

CN(1)