Alzheimer's disease Nervous System Diseases Alzheimer's disease
Conditions
Interventions
Block randomisation will be performed using a trial management system “Trial Controller” designed by our research group. 120 patients will be randomised in a 2:1 (Active:Placebo) masked fashion.
Sponsors
Now-Science Consultancy Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of mild to moderate Alzheimer's disease 2. Aged >65 years
Exclusion criteria
Exclusion criteria: 1. Consumption of carotenoids and/or omega supplements within the last 3 months 2. Inability to swallow capsules 3. Depression (under active review and medication change) 4. Previously confirmed stroke disease and/or infarct on brain scan 5. Mini-Mental State Evaluation (MMSE) >24 6. Intact clock drawing test and semantic fluency test (i.e. naming more than 11 objects starting with the letter F in 1 minute)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AD progression assessed using using mini mental state examination (MMSE) at baseline (visit 1), 12 months (visit 2) and 24 months (final visit). MMSE is a 30-point questionnaire that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Mild to moderate AD is defined as score of 10 to 25. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of life, assessed using using Quality of life in Alzheimer's Disease family and Participant version (QOL-AD). QOL-AD is a 13-item scale (total score range 13–52; higher scores indicate better QOL). The QOL-AD scale uses a scale of 1–4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient’s physical health, mood, relationships, activities, and ability to complete tasks. The researcher will interview the patient and patient’s carer separately. 2. Functional ability assessed using Dementia Severity Rating Scale (DSRS) and Clinical frailty score. 2.1. The DSRS is an informant-based, multiple-choice questionnaire that assesses severity from the mildest to the most severe stages in the major functional and cognitive domains affected in AD. Sections include: memory, speech and language, recognition of family members, orientation to time, orientation to place, ability to make decisions, social and community activity, home activities and responsibilities, personal care/cleanliness, eating, control of urination and bowels, and ability to get from place to place. Results are interpreted by adding up the points for all sections. Score of 0-18: mild, score of 19-36: moderate, and score of 37-54: severe. 2.2. Clinical frailty score (0-9) is recorded by the research nurse using a visual analogue scale. It is expected that mild to moderate AD patients will have a high score (i.e. 7). Functional ability will be evaluated by assessing the scores of each test over time (i.e. improvements, no changes and/or decline over 24 months). 3. Clinical collateral: a descriptive “story” of each subject will be recorded by the researcher including an interview of the patient’s carer (the primary person responsible for caring for the patient with Alzheimer's disease) to assess the patient’s health status and medical observations. Structured questions include: 3.1. Have you | — |
Countries
Ireland
Outcome results
None listed