A Phase II pilot study to determine protocol feasibility, and potential efficacy for disease modification of combined Doxycycline and Ambroxol in Dementia with Lewy Bodies

Phase 2

Recruiting

• Conditions: Dementia with Lewy Bodies; Neurological - Dementias

• Registration Number: ACTRN12623000004662
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-09
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Diagnosis of probable DLB according to the Fourth Consensus Report of the DLB Consortium
2. Ability to provide written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local regulations
3. Male or female aged 60 years or over as of the date of Baseline visit
4. Stabilised on optimal symptomatic treatment for a minimum of 4 weeks prior to the screening visit, with no changes expected throughout the study
5. Liver Function Tests (LFTs): alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 × upper limit of normal (ULN); total bilirubin less than or equal to 1.5 × ULN; serum albumin less than or equal to 2.8 g/dL
6. Men must agree to use highly effective, double barrier contraception during the study. Double barrier contraception is defined as a condom and one other form of the following: a. Contraceptive pill b. Depot or injectable birth control c. Intrauterine Device (IUD) d. Birth control patch (e.g. Ortho Evra) e. NuvaRing® f. Documented evidence of surgical sterilization at least 6 months prior to the screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men. Must be willing to remain on their current form of contraception for the duration of the study.
7. Willing and able to undergo trial assessments (e.g. venepuncture, ECG)
8. Willing and able to take oral drug therapy according to the study protocol

Exclusion Criteria

1. Participation in a clinical trial within the past 3 months, or current use of study IP
2. Known hypersensitivity to any of the IPs or their constituents
3. BMI < 18.5
4. History of significant medical event/s within 6 months prior to the screening visit, at the discretion of the PI
5. Use of typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to screening that in the opinion of the PI might account for parkinsonism
6. Gastrointestinal conditions that may affect the absorption of IP (e.g., ulcerative colitis, gastric bypass)
7. Serious neurological disorder (e.g., epilepsy) other than DLB
8. History of head trauma with loss of consciousness for more than 5 minutes within the past 6 months
9. Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic; sustained is defined as the average of 3 observations, each at least 10 minutes apart, with the participant having been supine and at rest for at least 5 minutes prior to each measurement
10. Abnormal 12-lead ECG results, which in the opinion of the investigator would preclude participation in the study
11. Prior diagnosis of cancer and evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or in situ prostate cancer with normal prostate-specific antigens post resection)
12. Any major surgical procedure within 30 days prior to the screening visit
13. Severely impaired renal function with creatinine clearance < 30 mL/min
14. Active alcohol or substance use disorder within the past 12 months
15. Depression of moderate severity or more on the Patient Health Questionnaire (PHQ-9) greater than or equal to score of 10 at the screening visit.
16. History of uncontrolled psychotic symptoms or history of a suicidal attempt/s within the prior 6 months.
17. Any condition or laboratory test result, which in the investigator's judgment might result in an increased risk to the participant or would affect their participation in the study.
18. Participation in any trial of a device [including, but not limited to Transcranial magnetic stimulation (TMS)], Near infrared light (NIr) and red light therapy (lambda = 600–1070 nm), investigational medicinal product, supplement, surgical treatment, cognitive/behavioural therapy, physiotherapy, health food supplements or active exercise study within 30 days prior to the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified