Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)

March 16, 2022 updated by: Zhijun Bao

Effects of Huperzine A on Presbycusis-related Subjective Tinnitus and Cognitive Impairment

To investigate the effects of huperzine A on tinnitus suppression, hearing and cognitive function protection in patients with presbycusis-related subjective tinnitus and cognitive impairment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, controlled trial. 60 eligible participants in total will be recruited. Participants in each group will be evenly and randomly assigned to the huperzine A subgroup and control subgroup using simple randomization method. Participants in the treatment subgroup will receive huperzine A (a dose of 0.2 mg/time, 2 times/day) with basic treatment and health education(BTHE), and those in the control subgroup will receive BTHE only. The primary outcome (auditory function) and secondary outcomes (tinnitus, cognitive symptom and quality of life) will be evaluated at baseline, 3-, 6-, 12-month follow-up.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huadong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

(1) 60 to 85 years old; (2) Mild-to-moderate sensorineural hearing loss (the pure tone averaged across octave frequencies between 0.25 to 4kHz of 26-70 dB HL), with subjective tinnitus, subjective cognitive decline or mild cognitive impairment; (3) Able to tolerate huperzine A treatment; (4) more than 3 months' experience of constant tinnitus; (5) Tinnitus Handicap Inventory score values >10; (6) No participation in any other clinical trial in the past 3 months; (7) Able to accomplish relevant tests and follow-up.

Exclusion Criteria:

(1) Conductive hearing loss; (2) current (3+ months) hearing aid(s) user; (3) Dependence due to poor physical activity; (4) Allergic to huperzine A; (5) History of malignancy within 5 years or other serious medical conditions before screening, including severe bradycardia, hypotension, angina, asthma, ileus, renal insufficiency, neurological diseases (e.g. epilepsy), psychiatric disorder (e.g. schizophrenia, severe depression and anxiety); (6) Acute brain trauma and stroke within 2 weeks; (7) history of general pain disorder and the use of pain relief drugs on a regular basis; (8) Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before investigation starts. (9) Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices. (10) Ongoing serious life event; (11) Vision impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Huperzine A intervention
Huperzine A intervention: Huperzine A with a dose 0.1~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education
Drug: BTHE and Huperzine A
huperzine A intervention
Other Names:
  • acetylcholinesterase inhibitor
Other: BETH
basic treatment and health education
Sham Comparator: control
Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.
Drug: BTHE and Huperzine A
huperzine A intervention
Other Names:
  • acetylcholinesterase inhibitor
Other: BETH
basic treatment and health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hearing function protection
Time Frame: 1 years

All participants (including with tinnitus and without tinnitus) will report in the measure.

Δ value of averaged hearing threshold = re-test threshold - initial threshold, Δ value of averaged hearing threshold ≤ 0 showed good responders, and > 0 showed poor responders.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global cognitive function protection
Time Frame: 1 years

All participants (including with tinnitus and without tinnitus) will report in the outcome measure.

ΔMMSE = re-test MMSE - initial MMSE, ΔMMSE< 0 showed poor responders and hearing threshold ≤ 0 showed good responders; and > 0 showed poor responders ΔMMSE≥ 0 showed good responders
1 years
special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands
Time Frame: 1 years
MMSE scale in different domains (MMSE SCALE, 0-30)
1 years
Tinnitus suppression
Time Frame: 1 years
150 participants with tinnitus will report in the outcome measure. Method 1: tinnitus functional index (0~100，≤25，relatively mild tinnitus; 25~50,significant problems with tinnitus; ≥50, tinnitus severe enough ）. method 2:no effect on tinnitus was showed "0"; symptomatic alleviation was showed "1";and tinnitus disappear was showed "2"
1 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events related to treatment of Huperzine A
Time Frame: 1years
All participants (including with tinnitus and without tinnitus) will be observed gastrointestinal side effects (nausea, vomiting diarrhea)in yes or no, dizziness, fatigue and insomnia in yes or no
1years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhijun Bao

Investigators

  • Study Director: zhuowei yu, MD, Shanghai Institute of Geriatrics and Gerontology, Shanghai Key Laboratory of Clinical Geriatrics, Huadong Hospital, and Research Center of Aging and Medicine, Shanghai Medical College, Fudan University, Shanghai 200040, China.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • huadong FudanU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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