None listed
Conditions
Brief summary
This study will evaluate whether a simple eye test could detect Alzheimer’s disease earlier than current techniques. We have already found some changes to the blood vessels in the retina, at the back of the eye, in Alzheimer’s disease. This new study will investigate if amyloid plaques, the hallmark of Alzheimer’s disease in the brain, also occur in the retina. A specialised eye camera will be used to take photographs of the retina. In order to highlight amyloid plaques in these photographs, participants will be asked to take a pudding containing Curcumin once per day for 7 days. Curcumin, the main ingredient of the common food spice turmeric, has been reported to have many beneficial health effects, and is being tested in other trials for possible therapeutic benefit in Alzheimer’s disease. Curcumin also has molecular and optical properties that may enable us to image amyloid plaques and hence detect Alzheimer’s disease earlier. It is hoped that this technique could allow us to detect Alzheimer’s disease before the cognitive signs become apparent, hence participants with normal cognition as well as those with memory problems and diagnosed Alzheimer’s disease will be recruited for this study.
Interventions
20 gm curcumin will be taken daily
Oral curcumin will begin on the morning of day 1 and dosing will occur once daily for seven consecutive days.
Curcumin is granular in consistency and not water soluble. For palatability, participants will be provided with a choice of pudding or shake in which to mix their daily dose of curcumin. One option will be dairy-free for lactose-intolerant individuals.
Participants will be asked to take an over the counter vitamin E supplement capsules equivalent t
20 gm curcumin will be taken daily Oral curcumin will begin on the morning of day 1 and dosing will occur once daily for seven consecutive days. Curcumin is granular in consistency and not water soluble. For palatability, participants will be provided with a choice of pudding or shake in which to mix their daily dose of curcumin. One option will be dairy-free for lactose-intolerant individuals. Participants will be asked to take an over the counter vitamin E supplement capsules equivalent to 500 IU daily beginning at the baseline visit (1 day prior to commencing curcumin) and continuing through the final day of curcumin dosing. Participants will be asked to maintain a Dosing Diary Card recording the dates and times of dosing with curcumin and Vitamin E capsules, to assess compliance.
Sponsors
McCusker Alzheimer's Research Foundation
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A Diagnosis of Alzheimer’s Disease (AD), Mild Cognitive Impairment (MCI), and healthy controls (HC) as per the 'The Australian Imaging Biomarkers and Lifestyle (AIBL) Flagship Study of Ageing' criteria ( International Psychogeriatrics / Volume 21 / Issue 04 / August 2009, pp 672-687), stratified as follows: AD – 10 patients (all Pittsburgh compound B positive (PiB+)) with mild to moderate AD - excluding severe AD) MCI – 10 patients (5 PiB+, 5 PiB-) HC – 20 patients (10 PiB+, 10 PiB-) Participant must be able to provide informed consent. Participant must be able to assign an individual who will help with recording protocol compliance. Male or Female 'greater than or equal to' 50 years old Clear ocular media and pupillary dilation to allow for ocular imaging.
Exclusion criteria
Patients cannot have major cognitive impairment not associated with AD including a past history or magnetic resonance imaging (MRI) evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder History of alcoholism or drug addiction within the past year A score of greater than 4 on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease Systemic illness that could influence the patient’s safety and compliance with the protocol e.g., severe hepatic, renal, cardiovascular or metabolic diseases that would significantly increase patient’s risk to participate in protocol Advanced retinal disease, cataracts or other ocular conditions that may affect clear images of the retina. Patients with current or previous bile duct obstruction, gallstones, and gastrointestinal disorders (including stomach ulcers and hyperacidity disorders) Patients who are pregnant or breast feeding Hostility or refusal to cooperate Participation in another clinical trial within 30 days prior to the baseline visit (with the exception of the AIBL trial)
Outcome results
None listed