Amisulpride Treatment for BPSD in AD Patients

Amisulpride Versus Olanzapine Treatment for Behavioral and Psychological Symptoms in Patients With Dementia of the Alzheimer Type:A Randomized, Open-label, Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: BPSD; Amisulpride; Olanzapine; Dementia of the Alzheimer Type
• Intervention / Treatment: Drug: Amisulpride; Drug: Olanzapine

Detailed Description

This study was a randomized, open-label, prospective clinical study in which patients were randomized to receive amisulpride and olanzapine for 8 weeks. Drug efficacy and safety assessments were assessed at baseline, 2 weekends, 4 weekends, and 8 weekends.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Recruiting
      • Tianjin Anding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. It conforms to the diagnostic standard of Alzheimer's disease in International Classification of Diseases 10th Revision (ICD-10)
2. a total score of MMSE<24
3. The patients had active behavioral symptoms with a minimum score of 20 on the 12-point Neuropsychiatric Inventory (NPI)
4. 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amisulpride group; The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.	Drug: Amisulpride; The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.; Other Names: Solian
Active Comparator: Olanzapine group; The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.	Drug: Olanzapine; The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.; Other Names: Oulanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Clinical global impression-Severity of Illness (CGI-SI) score	The change from baseline Clinical global impression-Severity of Illness (CGI-SI) score. The highest score is 7 points. A higher score indicates a more serious disease or a tendency to worsen The change from baseline Clinical global impression-Severity of Illness (CGI-SI) score. The highest score is 7 points. A higher score indicates a more serious disease or a tendency to worsen	baseline, Week 2,4, and 8
Changes of Clinical global impression- global improvement (CGI-GI)	The change from baseline Clinical global impression- global improvement (CGI-GI) items at week 2,4,and 8. The highest score is 7 points. A higher score indicates a more serious disease or a tendency to worsen	baseline, Week 2,4, and 8
Changes of Mini-Mental State Examination(MMSE) scores.	The change from baseline Mini-Mental State Examination(MMSE) items at week 2,4,and 8.The content includes time orientation, location orientation, immediate memory of language, attention and calculation, short-term memory, physical naming, language repeating, reading comprehension, speech expression and graphic description. 0 to 30 points, the lower the score, the more severe the cognitive impairment.	baseline, Week 2,4, and 8
Changes of Caregiver Burden Inventory (CBI) scores	The change from baseline Caregiver Burden Inventory (CBI) items at week 2,4,and 8.The questionnaire contains 5 dimensions: time-dependent burden, development-restricted burden, physical burden, social burden, and emotional burden. The total score is 96 points. The higher the score, the heavier the burden.	baseline, Week 2,4, and 8
Treatment Emergent Symptom Scale (TESS)	The scale collection includes 33 items of consciousness disorder, constipation, tremor, etc., to assess the adverse drug reactions and their severity.This table is used to evaluate 33 items of common consciousness disorder, constipation, tremor, etc. based on the adverse drug reactions. Each item is scored according to the severity of the adverse drug reactions. This scale does not need to be evaluated at baseline.	Week 2,4, and 8
Rating scale for extrapyramidal side effects (RSESE)	Assessment of extrapyramidal reactions and their severity at various time points.Assess the severity of 9 aspects of gait, falling arms, shaking shoulders, elbow rigidity, fixed posture or wrist rigidity, leg swings, head and neck movements, tapping between eyebrows, drooling，The total score is 36 points. The higher the score, the more severe extrapyramidal side effects.	baseline, Week 2,4, and 8
Abnormal Involuntary Movement Scale (AIMS)	Assesses whether patients have involuntary movements and their severity in the face, limbs, and trunk at various time points.Assess facial movements, body movements, and trunk movements for involuntary movements and severity. A total score of 2 or more is masculine gender.	baseline, Week 2,4, and 8

Collaborators and Investigators

• Sponsor: Tianjin Anding Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Olanzapine; Amisulpride
• Other Study ID Numbers: AMI-2019-BPSD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No