Randomised double-blind placebo controlled trial of effect of Ginkgo biloba on cognitive function in mild-moderate dementia

ISRCTN	ISRCTN45577048
DOI	https://doi.org/10.1186/ISRCTN45577048
Secondary identifying numbers	QRD/2001/01/07

Submission date: 02/08/2002
Registration date: 02/08/2002
Last edited: 11/07/2007

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 of protocol

Not provided at time of registration

Contact information

Dr James Warner
Scientific

Senior Lecturer
Imperial College School of Medicine
St Charles Hospital
Exmoor Street
London
W10 6DZ
United Kingdom

Phone	+44 (0)20 8962 4101
Email	j.warner@ic.ac.uk

Study information

Study design	Randomised double-blind placebo controlled parallel group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Not Specified
Scientific title
Study acronym	DIGGER
Study objectives	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.
Ethics approval(s)	Received from Multi-centre Research Ethics Committee (ref: MREC/02/6/35).
Health condition(s) or problem(s) studied	Dementia
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ginkgo extract
Primary outcome measure	Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) at six months.
Secondary outcome measures	All at six months: 1. Participant: Quality of Life scale in Alzheimers 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)
Overall study start date	01/04/2003
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Target: 200
Key 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
Key exclusion criteria	1. Commencement of acetylcholinesterase therapy within two months of recruitment 2. Current anticoagulant therapy 3. Abnormal clotting profile
Date of first enrolment	01/04/2003
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Senior Lecturer

London
W10 6DZ
United Kingdom

Sponsor information

Alzheimer's Society (UK)
Charity

Gordon House
10 Greencoat Place
London
SW1P 1PH
United Kingdom

Phone	+44 (0)20 7306 0606
Email	enquiries@alzheimers.org.uk
"ROR"	https://ror.org/0472gwq90

Funders

Funder type

Charity

Alzheimer's Society (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): alzheimerssoc
Location: United Kingdom

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	03/07/2007		Yes	No