Doxycycline And Rifampin for Alzheimer's Disease
| ISRCTN | ISRCTN15039674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15039674 |
| Secondary identifying numbers | MCT-79779 |
- Submission date
- 06/10/2006
- Registration date
- 06/10/2006
- Last edited
- 19/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr David William Molloy
Scientific
Scientific
St.Peter's Hospital
Centre for Studies in Aging
88 Maplewood Avenue
Hamilton
Ontario
L8M 1W9
Canada
Study information
| Study design | Multi-centre, randomised factorial, four leg trial using placebo, with study participant, investigator, caregiver, outcome assessor and data analyst blinded. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Multi-centre, blinded, randomised, controlled trial comparing different regimens of the antibiotics Doxycycline and Rifampin for treatment of Alzheimer's Disease |
| Study acronym | DARAD |
| Study hypothesis | Treatment with doxycycline and rifampin will slow or stop the progression of Alzheimers disease compared to those taking a placebo. Primary objective: To determine the impact of rifampin and doxycycline, over a one year period on cognition, function, mood, and behaviour. Secondary objective: To determine if treatment with either doxycycline or rifampin alone is as efficacious as the combined treatment. |
| Ethics approval(s) | Ethics approval received from the Research Ethics Board of Hamilton Health Sciences and McMaster University (Canada) on the 11th April 2006 |
| Condition | Alzheimer's disease |
| Intervention | Experimental group 1: Doxycycline 100 mg twice daily (b.i.d.) plus placebo matched to rifampin 300 mg once daily (o.d.) for 12 months Experimental group 2: Rifampin 300 mg o.d. plus placebo matched to doxycycline 100 mg b.i.d for 12 months Experimental group 3: Doxycycline 100 mg b.i.d. for 12 months plus placebo matched to rifampin 300 mg o.d. for 12 months Control group: Placebo matched to doxycycline containing microcrystalline cellulose 100 mg b.i.d. plus rifampin containing microcrystalline cellulose 300mg o.d. for 12 months The public contact for this trial is: Tim Standish, MA St.Peter's Centre for Studies in Aging St.Peter's Hospital, Hamilton, ON Canada Phone: +1 (905) 777-3837 ext. 12442 Email: tstandish@stpetes.ca |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxycycline and rifampin |
| Primary outcome measure | 1. Standardised Alzheimer's Disease Assessment Scale - Cognitive Subscale (SADAS-cog), measured at 12 months 2. Clinical Dementia Rating Scale (CDR), measured at 12 months |
| Secondary outcome measures | 1. SMMSE, measured at 12 months 2. AB Cognitive Screen 100 (ABCS 100), measured at 12 months 3. Geriatric Depression Scale (GDS), measured at 12 months 4. Lawton Scale, measured at 12 months 5. Dysfunctional Behaviour Rating Instrument (DBRI), measured at 12 months |
| Overall study start date | 01/05/2006 |
| Overall study end date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Participant inclusion criteria | 1. Probable Alzheimer's disease 2. Aged 50 - 99 years old, either sex 3. Standardised Mini Mental State Examination (SMMSE) score 14 to 26 inclusive 4. Consenting patient (or Power of Attorney [POA] consents for patient) 5. Consenting caregiver 6. Sufficient English to complete standardised testing in English 7. May reasonably be expected to complete a one year trial |
| Participant exclusion criteria | 1. Other neuro-degenerative diseases such as Lewy body, Parkinson's, fronto-temporal, Huntington's Chorea, Down's Syndrome or Creutzfeld Jacob Disease 2. Cognitive impairment due to acute cerebral trauma, subdural haematoma, injuries from chronic trauma, hypoxic cerebral damage 3. B12 deficiency, cancer or infections e.g. acquired immune deficiency syndrome (AIDS) 4. Endocrine deficiencies 5. Hypercalcemia, hypothyroidism, hyperparathyroidism, Cushing's syndrome, severe renal failure, poorly controlled diabetes mellitus, pituitary disease, etc. 6. Mental retardation 7. Significant cerebrovascular disease or multi-infarct dementia 8. Intra-cranial pathology, tumour or hydrocephalus 9. Co-existing medical conditions such as history of epilepsy or convulsions 10. Clinically significant psychiatric conditions or moderate to severe behavioural disturbances 11. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine diseases 12. History of drug or alcohol abuse 13. History of myasthenia gravis 14. Clinically significant cardiac disease such as cardiac surgery in the past six months, unstable angina or poorly controlled congestive heart failure, uncontrolled hypertension with systolic pressure greater that 180 mmHg or diastolic pressure greater that 110 mmHg 15. Anti-dementia treatments except donepezil, galantamine, rivastigmine, memantine, acetylsalicylic acid (ASA) up to 650 mg OD, Vitamin E 400 i.u., multi B vitamins, Ginko biloba, Cyclooxygenase Type II (Cox II) inhibitors or statins 16. Other investigational drugs 17. Long-term antibiotics 18. Allergy to doxycycline or rifampin |
| Recruitment start date | 01/05/2006 |
| Recruitment end date | 30/11/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
St.Peter's Hospital
Ontario
L8M 1W9
Canada
L8M 1W9
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 |
|---|---|
| hsresadm@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79779)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No | |
| Results article | results | 01/05/2019 | 19/08/2020 | Yes | No |
Editorial Notes
19/08/2020: Publication reference added.
17/01/2019: Publication reference added.
