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

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;

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease; Cognitive Function
• Intervention / Treatment: Drug: Tandospirone Citrate; Drug: Donepezil Hydrochloride

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 55-80 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.

Exclusion Criteria:

• 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.

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: Experimental group	Drug: Tandospirone Citrate; Tandospirone, 30-60 mg/d; Drug: Donepezil Hydrochloride; Donepezil, 10 mg/d
Other: Control group	Drug: Donepezil Hydrochloride; Donepezil, 10 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAMA total score	HAMA total score at week 12	week 12
FAB score	FAB score at week 12	week 12
relative power	Change from baseline in the relative power at week 12	week 12
the image of PET	the image of PET at week 12	week 12
MMSE score	MMSE score at week 12	week 12

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Alzheimer Disease; Cognitive Function; tandospirone
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Cholinergic Agents; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Anti-Anxiety Agents; Nootropic Agents; Cholinesterase Inhibitors; Donepezil; Tandospirone
• Other Study ID Numbers: SED-AD; SED-AD-2016-001 (Other Identifier: Sumitomo Pharma （Suzhou） Co..Ltd)

Drug and device information, study documents

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