| Source of record | UK Trials |
| ISRCTN | ISRCTN45577048 |
| Date ISRCTN assigned | 02/08/2002 |
| Local reference number(s) | QRD/2001/01/07 |
| Public title | Randomised double-blind placebo controlled trial of effect of Ginkgo biloba on cognitive function in mild-moderate dementia |
| Scientific title |
|
| Acronym | DIGGER |
| Disease/condition/study domain | Dementia |
| Study hypothesis | Null Hypothesis: high purity ginkgo biloba extract does not improve cognition quality of life or carer burden in individuals with mild-moderate dementia. NB: this study will also assess the magnitude of the Hawthorne effect in dementia trials. |
| Design/methodology | Randomised double-blind placebo controlled parallel group study |
| Research ethics review | Received from Multi-centre Research Ethics Committee (ref: MREC/02/6/35). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 55 years and over
2. Clinician's diagnosis of dementia
3. Presence of a carer
4. Consent of patient and carer
5. Sufficient command of English to complete questionnaires
6. Mini Mental State Examination (MMSE-23) score of 15 - 24 |
| Participants - exclusion criteria | 1. Commencement of acetylcholinesterase therapy within two months of recruitment
2. Current anticoagulant therapy
3. Abnormal clotting profile |
| Patient information material |
|
| Anticipated start date | 01/04/2003 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Target number of participants | Target: 200 |
| Interventions | 1. The active intervention will be concentrated, standardised Ginkgo biloba extract (25% active Ginkgo-flavoneglycosides), prepared according to accepted guidelines in a 60 mg tablet (EGB-761, Schwabe)
2. The placebo will be 60 mg of inert lactose with 2 mg quinine sulphate |
| Primary outcome measure(s) | Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) at six months. |
| Secondary outcome measure(s) | All at six months:
1. Participant: Quality of Life scale in Alzheimer¿s disease (QoL-AD), Neuropsychiatric Inventory questionnaire (NPI), Geriatric Evaluation by Relative's Rating Instrument (GERRI), adverse events
2. Carer: European Quality of life questionnaire (EQ-5D), Zarit caregiver Burden Interview (ZBI) |
| Publications | Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=17608932 |
| Sources of funding | Alzheimer's Society (UK) |
| Sponsor name | Alzheimer's Society (UK) |
| Sponsor details | Gordon House
10 Greencoat Place
London
United Kingdom
SW1P 1PH |
| Sponsor telephone | +44 (0)20 7306 0606 |
| Sponsor fax | +44 (0)20 7306 0808 |
| Sponsor email | enquiries@alzheimers.org.uk |
| Contact name | Dr James Warner |
| Contact details | Senior Lecturer
Imperial College School of Medicine
St Charles Hospital
Exmoor Street
London
United Kingdom
W10 6DZ |
| Contact telephone | +44 (0)20 8962 4101 |
| Contact fax | +44 (0)20 8960 8112 |
| Contact email | j.warner@ic.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN45577048 |
| Date last extracted from ISRCTN register | 17/04/2008 |
