A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be 6-month placebo-controlled double-blind study (subjects, care givers, investigators and the sponsor will be blinded to the subjects' treatment). Study drugs will be 10 mg, 20mg of Buntanetap, or matching placebo, taken once a day in the morning. Qualified subjects will be randomly assigned at a 1:1:1 ratio to one of the three treatment arms: Buntanetap 10 mg, Buntanetap 20 mg, and placebo, through an Interactive Randomization System, after a screening period of up to 30 days. The total duration of open-label study participation will be 6-7 months. MDS-United Parkinson's Disease Rating Scale (MDS-UPDRS), Participant Global Impression of Change (PGIC), Weschler Adult Intelligence Scales (WAIS) coding, and Mini-Mental State Examination (MMSE) will be assessed by trained clinicians. All efforts will be made to ensure subjects will be assessed by the same clinician throughout the study. Participants should stop SOC Parkinson's medications 12 hrs before clinical visit to ensure clinical off-stage during visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Annovis Bio Inc.
• Collaborator: TFS Trial Form Support
• Treatments: Phenserine

Criteria

Inclusion Criteria:

• Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease

• H&Y score =1, 2 or 3 during ON stage

• Male or female aged 40 - 85 years

• MMSE score between the range of 20-30 and patients can live independently without a caregiver

• Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment

• Female participants will be given a urine pregnancy test at the screening visit for which they should test negative

• General cognition and functional performance sufficiently preserved that the subject can provide written informed consent

• No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale

• Stability of permitted medications prior to screening for at least 4 weeks

• At screening patients do not need to but may be on the following medication; 1)Standard of Care anti-parkinsonian medication (L-dopa or dopamine antagonists); 2)Anticonvulsant medications used for epilepsy or mood stabilization; neuropathic pain indications; 3)Mood-stabilizing psychotropic agents, including, but not limited to, lithium

• Adequate visual and hearing ability (physical ability to perform all the study assessments)

• Good general health with no disease expected to interfere with the study

• Subjects previously exposed to Buntanetap can still be included in the study after a 28- day wash out period

Exclusion Criteria:

• Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Mild depression or history of depression that is stable on treatment with a SSRI or SNRI medication at a stable dose is acceptable.

• History of a seizure disorder

• Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 475ms, or torsades de pointes

• Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening

• Has uncontrolled Type-1 or Type-2 diabetes. A Subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control

• Has clinically significant renal or hepatic impairment

• Has any clinically significant abnormal laboratory values. Subjects with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal will be excluded

• Is at imminent risk of self-harm, based on clinical interview and responses on the C SSRS, or of harm to others in the opinion of the Investigators. Subjects must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g. positive response to Items 4 or 5 in assessment of suicidal ideation on the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months

• Has cancer or has had a malignant tumor within the past year, except patients who underwent potentially curative therapy with no evidence of recurrence. (Patients with stable untreated prostate cancer or skin cancers are not excluded)

• Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM

• Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 60 days prior to the start of screening. The end of a previous investigational trial is the date the last dose of an investigational agent was taken, or five half-lives of the investigational drug, whichever is greater

• Subjects with learning disability or developmental delay

• Subjects whom the site PI deems to be otherwise ineligible