Condition category
Nervous System Diseases
Date applied
06/10/2006
Date assigned
06/10/2006
Last edited
14/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David William Molloy

ORCID ID

Contact details

St.Peter's Hospital
Centre for Studies in Aging
88 Maplewood Avenue
Hamilton
Ontario
L8M 1W9
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-79779

Study information

Scientific title

Multi-centre, blinded, randomised, controlled trial comparing different regimens of the antibiotics Doxycycline and Rifampin for treatment of Alzheimer's Disease

Acronym

DARAD

Study hypothesis

Treatment with doxycycline and rifampin will slow or stop the progression of Alzheimer’s 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

Ethics approval received from the Research Ethics Board of Hamilton Health Sciences and McMaster University (Canada) on the 11th April 2006

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Doxycycline and rifampin

Primary outcome measures

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 trial start date

01/05/2006

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

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

Trial participating centre

St.Peter's Hospital
Ontario
L8M 1W9
Canada

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140
hsresadm@mcmaster.ca

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79779)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes