CClinicalTrials.gg
Sign In
Status unknownNCT03151382Updated May 12, 2017

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

A Phase 4 interventional study of Tandospirone Citrate and Donepezil Hydrochloride in Alzheimer Disease and Cognitive Function, sponsored by Zhejiang Provincial People's Hospital. Status unknown. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-12.

Sponsored by Zhejiang Provincial People's Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
01

Study 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;

02

Conditions studied

  • Alzheimer Disease
  • Cognitive Function

Browse trials for

Keywords

  • Alzheimer Disease
  • Cognitive Function
  • tandospirone
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Drug: Tandospirone Citrate · Drug: Donepezil Hydrochloride

  • Other
    Control group

    Drug: Donepezil Hydrochloride

Interventions

  • DrugTandospirone Citrate

    Tandospirone, 30-60 mg/d

  • DrugDonepezil Hydrochloride

    Donepezil, 10 mg/d

06

What researchers measure

Primary outcomes

  1. Change of ADAS-cog total score

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

    Time frame: week 12

  2. NPI scale total score

    NPI scale total score at week 12

    Time frame: week 12

Secondary outcomes

  1. HAMA total score

    HAMA total score at week 12

    Time frame: week 12

  2. FAB score

    FAB score at week 12

    Time frame: week 12

  3. relative power

    Change from baseline in the relative power at week 12

    Time frame: week 12

  4. the image of PET

    the image of PET at week 12

    Time frame: week 12

  5. MMSE score

    MMSE score at week 12

    Time frame: week 12

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03151382
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Enyan Yu (Secretary of Party Committee, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
May 12, 2017
Start date
May 20, 2017 (estimated)
Primary completion
Dec 31, 2017 (estimated)
Completion
Jun 30, 2018 (estimated)
Last update
May 12, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alzheimer Disease→

Other studies from this sponsor

Zhejiang Provincial People's Hospital

Start the discussion