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

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ClinicalTrials.gov Identifier: NCT03101722
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zhijun Bao, Fudan University

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE April 5, 2017
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE May 15, 2017
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
hearing function protection [ Time Frame: 1-3 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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
  • 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)
  • 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"
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • global cognitive function protection [ Time Frame: 3 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
  • special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands [ Time Frame: 3 years ]
    MMSE scale in different domains (MMSE SCALE, 0-30)
  • Tinnitus suppression [ Time Frame: 3-6 months ]
    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"
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2019)
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
Original Other Pre-specified Outcome Measures
 (submitted: April 4, 2017)
  • Observation of liver and renal function [ Time Frame: 1-3years ]
    All participants (including with tinnitus and without tinnitus) will be observed. The levels of serum alanine aminotransferase (ALT) u/L, aspartate aminotransferase (AST) u/L, alkaline phosphatase(ALP)u/L, total bilirubin (TBIL) μmol/L and direct bilirubin (DBIL) μmol/L were each measured by immunoenzymatic assays; Plasma creatinine (mg/L), Uric acid (mg/dl) and Glomerular filtration rate (ml/min/1.73m2).
  • adverse events related to treatment of Huperzine A [ Time Frame: 1-3years ]
    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
 
Descriptive Information
Brief Title  ICMJE Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)
Official Title  ICMJE Effects of Huperzine A on Presbycusis-related Subjective Tinnitus and Cognitive Impairment
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The studies were divided into 2 groups: Control subgroup and huperzine A group.The study is a single-center, randomized, basic treatment and health education controlled trial, with minimized allocation of patients to one of the two groups.

For the study of tinnitus intervention, there is a 3 to 12 month follow-up.

Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Presbycusis
  • Tinnitus
  • Cognitive Impairment
Intervention  ICMJE
  • Drug: BTHE and Huperzine A
    huperzine A intervention
    Other Name: acetylcholinesterase inhibitor
  • Other: BETH
    basic treatment and health education
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: BTHE and Huperzine A
    • Other: BETH
  • Sham Comparator: control
    Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.
    Interventions:
    • Drug: BTHE and Huperzine A
    • Other: BETH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2017)
550
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03101722
Other Study ID Numbers  ICMJE huadong FudanU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhijun Bao, Fudan University
Study Sponsor  ICMJE Zhijun Bao
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Fudan University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP