A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease

NCT03151382 | Unknown Phase 4

• 2 other identifiers: SED-ADSED-AD-2016-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with AD comorbid anxiety. Number of Patients: 30 Methodology: Randomized, open-label, parallel-group Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control group: Donepezil, 10 mg/d. Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12; NPI scale total score at week 12;

Conditions

Alzheimer Disease; Cognitive Function

Keywords

Alzheimer Disease; Cognitive Function; tandospirone

Outcome Measures

Primary Outcomes (2)

• Change of ADAS-cog total score

  Change from baseline in ADAS-cog total score at week 12

  week 12

• NPI scale total score

  NPI scale total score at week 12

  week 12

Secondary Outcomes (5)

• HAMA total score

  week 12

• FAB score

  week 12

• relative power

  week 12

• the image of PET

  week 12

• MMSE score

  week 12

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Tandospirone Citrate; Drug: Donepezil Hydrochloride

Control group

OTHER

Drug: Donepezil Hydrochloride

Interventions

Tandospirone Citrate DRUG

Tandospirone, 30-60 mg/d

Experimental group

Donepezil Hydrochloride DRUG

Donepezil, 10 mg/d

Control group; Experimental group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment;
• Patients who were diagnosed with AD according to the DSM-IV;
• MMSE score \> 10 and ≤ 24;
• HAMA score \> 8;
• HAMD score ≤ 7;
• Brain CT or MRI supports the diagnosis of AD;
• Provide written informed consent by the patient himself and his family member or guardian.

You may not qualify if:

• Dementia from any other cause;
• Brain MRI showed that the diameter of hyperintense lesions in T2-FLAIR sequences were larger than 5mm;
• Patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease;
• Any primary neurologic or psychiatric disease other than AD;
• Mental disorders due to substance abuse;
• Participation in other clinical studies within the last 30 days;
• History of alcohol or substance abuse or dependence within the past year;
• Pregnant or breastfeeding, or of child-bearing potential during the study.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary of Party Committee

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: May 20, 2017
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: May 12, 2017

Record last verified: 2017-05