Alzheimer Disease; Prodromal Clinical Trial
— MIND-ADminiOfficial title:
Multimodal Preventive Trial for Alzheimer's Disease (MIND-ADmini Pilot Trial)
| Verified date | September 2021 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal lifestyle intervention among patients with prodromal AD.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | December 18, 2020 |
| Est. primary completion date | December 23, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years to 85 Years |
| Eligibility | Inclusion criteria: A) Prodromal AD as defined as -1 SD on 2 out of 8 tests, at least 1 memory: Memory FCSRT - delayed free recall* = 8 FCSRT free recall - learning = 22 WMS-R story delayed recall (%) =75% WMS-R delayed recall of figures (%) = 75% *Free and Cued Selective reminding test Non-memory TMT A = 60 TMT B = 150 Symbol Digit Substitution Test = 35 (120 sec.) Category Fluency = 16 (60 sec.) - Evidence for underlying AD pathology within 2 year prior to screening by either: 1. CSF beta amyloid 1-42/1-40x10 ratio<1 and/or elevated T-tau and/or elevated phospho-tau and/or low beta amyloid 42 based on local lab cut-offs OR 2. MRI evidence for medial temporal lobe atrophy (MTA score 1 or higher) OR 3. Abnormal FDG PET and/or PiB PET compatible with AD type change B) Potential for lifestyle improvement, defined according to a Lifestyle Index. Lifestyle index. Participants with a score of 3 or above are included in the study. The lifestyle index identifies individuals who do not already have very healthy lifestyles, and thus have a margin for improving their lifestyle based on the MIND-AD intervention. The score is calculated by adding 1 point for each of the following factors: - Physical activity less than 2.5 hours a week (defined as physical activity intensive enough to lead to sweating and some breathlessness) - Diet - less than 5 portions of fruits and vegetables per day - Diet - less than 2 portions of fish per week - Hypertension (diagnosed by physician or current antihypertensive treatment or - SBP>140mmHg or DBP>90 mmHg) - Diabetes (type 1 or 2 diagnosed by physician; or current diabetes medication; or recorded elevated fasting blood glucose or HbA1C as per local guidelines within the past 6 months) - Ongoing symptoms of sleep problems, depressive symptoms or psychological stress symptoms for at least 1 month, judged by the clinician as having some impact on everyday life C) Age 60-85 D) MMSE = 24 E) Availability of a responsible study partner. F) Written informed consent from participant as well as study partner G) Putative prescription cognitive enhancers (e.g. ginkgo, cholinesterase inhibitors) and statins are not excluded but the dosage should be stable prior to randomization. Doses should be kept stable during the study if possible. Exclusion criteria - Dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) - Use of omega-3 preparations > 500mg EPA+DHA per day - Alcohol or drug abuse - A concomitant serious disease - Major depressive disorder (DSM-IV) - Regular intake of supplements for vitamin B6, B12, folic acid, vitamin C and/or E > 200% RDI, unless prescribed by physician - Participation in any other clinical trial in the last 30 days - Subjects with MRI (or CT) scan consistent with a diagnosis of stroke, intracranial bleeding, mass lesion or NPH. Those subjects with a MRI scan demonstrating minimal white matter changes (Fazekas scale for white matter lesions <=3) and up to 1-2 lacunar infarcts which are judged to be clinically insignificant are allowed - Severe loss of vision or communicative ability - Conditions preventing cooperation as judged by the study physician - Concomitant participation in any intervention trial |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska University Hospital | Huddinge |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Universität des Saarlandes, University Hospital, Toulouse, University of Eastern Finland |
Sweden,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in Body Mass Index | Height (cm) and weight (kg) are used to calculate Body Mass Index | 6 months | |
| Other | Change in Hip-waist ratio | Hip and waist measurements (cm) are used for hip-waist ratio calculations | 6 months | |
| Other | Change in blood pressure | Including measurements of systolic blood pressure, diastolic blood pressure, and pulse pressure | 6 months | |
| Other | Change in blood lipids | Including measurements of serum total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides | 6 months | |
| Other | Change in glucose metabolism markers | Including measures of glucose, insulin, HbA1c | 6 months | |
| Other | Change in inflammation | CRP measures | 6 months | |
| Other | Depressive symptoms | Geriatric Depression Scale | 6 months | |
| Other | Stress-related symptoms | Perceived Stress Scale | 6 months | |
| Other | Physical performance | Timed 10-meter dual-task test & Short Physical Performance Battery (SPPB) | 6 months | |
| Other | Health-related quality of life | RAND36 | 6 months | |
| Other | Blood biomarkers | e.g lipid metabolism, inflammation, vitamins (e.g D & B) | 6 months | |
| Other | Self-reported adherence to each intervention component | The following intervention components: nutrition, exercise, cognitive training, monitoring of vascular factors | 6 months | |
| Primary | Recruitment rate | Recruitment rate of participants within a 6 months period | 6 months | |
| Primary | Overall adherence to the intervention | Overall adherence to the intervention during 6 months | 6 months | |
| Primary | Retention rate | Retention rate of participants during 6 months | 6 months | |
| Secondary | Adherence to intervention components | Intervention arms only | 6 months | |
| Secondary | Adherence to healthy lifestyle changes | All arms | 6 months |