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Multimodal Preventive Trial for Alzheimer's Disease (MIND-ADmini)

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ClinicalTrials.gov Identifier: NCT03249688
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborators:
University of Eastern Finland
INSERM-University of Toulouse
Saarland University
Information provided by (Responsible Party):
Miia Kivipelto, Karolinska Institutet

Brief Summary:
The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal lifestyle intervention among patients with prodromal AD.

Condition or disease Intervention/treatment Phase
Alzheimer Disease; Prodromal Other: Regular health advice Behavioral: Multidomain lifestyle Dietary Supplement: Medical food Not Applicable

Detailed Description:

Given the multifactorial etiology of Alzheimer's disease (AD), multimodal interventions targeting several risk factors and disease mechanisms simultaneously are most likely to be effective for preventing dementia. Multimodal lifestyle interventions have so far been tested in at-risk older adults from the general population, but not in patients with prodromal AD.

The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal lifestyle intervention among individuals with prodromal AD.

This 6-month pilot trial is planned to include 150 participants randomized into 3 arms:

  1. Control (regular health advice)
  2. Multidomain lifestyle intervention (nutritional guidance, exercise, cognitive training and monitoring and management of vascular and metabolic risk factors)
  3. Multidomain lifestyle intervention + medical food. The multidomain lifestyle intervention is adapted from the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER, NCT01041989). The medical food product includes the specific multi-nutrient combination Fortasyn Connect (containing the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), uridine monophosphate, choline, vitamins B12, B6, C, E, and folic acid, phospholipids, and selenium). The rationale for combining a multidomain lifestyle intervention with medical food is evidence indicating synergistic effects between different intervention components (e.g. omega-3 fatty acids and physical activity). Nutrient deficiencies have been described in AD, and medical food may be needed in addition to dietary guidance for optimal effect. The use of Fortasyn Connect alone in prodromal AD has been investigated in another clinical trial (www.lipididiet.eu), and thus this arm is not included in MIND-ADmini.

The 6-month MIND-ADmini pilot trial will be conducted in Sweden, Finland, Germany and France. An additional 6-month optional extension of the pilot trial will also be considered.

Primary outcome is feasibility of the multimodal intervention. Secondary outcomes include adherence to intervention components (intervention arms), and adherence to healthy lifestyle changes (all arms). Detailed cognitive assessments (Neuropsychological Test Battery, NTB) and functional assessments (Clinical Dementia Rating, CDR; and Alzheimer's Disease Cooperative Study-Activities of Daily Living, ADCS-ADL) will also be conducted at baseline and 6-month visit for the purpose of obtaining reliable estimates of change over time for power calculations for a future larger multimodal intervention trial (MIND-ADmaxi).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multimodal Preventive Trial for Alzheimer's Disease (MIND-ADmini Pilot Trial)
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
Regular health advice
Other: Regular health advice
Routine healthy lifestyle counseling

Experimental: Multidomain 1
Multidomain lifestyle
Behavioral: Multidomain lifestyle
Nutritional guidance, exercise, cognitive training, vascular risk monitoring

Experimental: Multidomain 2
Multidomain lifestyle + medical food
Behavioral: Multidomain lifestyle
Nutritional guidance, exercise, cognitive training, vascular risk monitoring

Dietary Supplement: Medical food
Medical food product (Fortasyn Connect)




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 6 months ]
    Recruitment rate of participants within a 6 months period

  2. Overall adherence to the intervention [ Time Frame: 6 months ]
    Overall adherence to the intervention during 6 months

  3. Retention rate [ Time Frame: 6 months ]
    Retention rate of participants during 6 months


Secondary Outcome Measures :
  1. Adherence to intervention components [ Time Frame: 6 months ]
    Intervention arms only

  2. Adherence to healthy lifestyle changes [ Time Frame: 6 months ]
    All arms


Other Outcome Measures:
  1. Change in Body Mass Index [ Time Frame: 6 months ]
    Height (cm) and weight (kg) are used to calculate Body Mass Index

  2. Change in Hip-waist ratio [ Time Frame: 6 months ]
    Hip and waist measurements (cm) are used for hip-waist ratio calculations

  3. Change in blood pressure [ Time Frame: 6 months ]
    Including measurements of systolic blood pressure, diastolic blood pressure, and pulse pressure

  4. Change in blood lipids [ Time Frame: 6 months ]
    Including measurements of serum total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides

  5. Change in glucose metabolism markers [ Time Frame: 6 months ]
    Including measures of glucose, insulin, HbA1c

  6. Change in inflammation [ Time Frame: 6 months ]
    CRP measures

  7. Depressive symptoms [ Time Frame: 6 months ]
    Geriatric Depression Scale

  8. Stress-related symptoms [ Time Frame: 6 months ]
    Perceived Stress Scale

  9. Physical performance [ Time Frame: 6 months ]
    Timed 10-meter dual-task test & Short Physical Performance Battery (SPPB)

  10. Health-related quality of life [ Time Frame: 6 months ]
    RAND36

  11. Blood biomarkers [ Time Frame: 6 months ]
    e.g lipid metabolism, inflammation, vitamins (e.g D & B)

  12. Self-reported adherence to each intervention component [ Time Frame: 6 months ]
    The following intervention components: nutrition, exercise, cognitive training, monitoring of vascular factors



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 60-80 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249688


Contacts
Contact: Miia Kivipelto, MD, PhD +46 8 585 838 85 miia.kivipelto@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Huddinge, Sweden, 14186
Contact: Miia Kivipelto, MD, PhD    +46739940922    miia.kivipelto@ki.se   
Contact: Shireen Sindi, PhD    +46735508703    shireen.sindi@ki.se   
Sponsors and Collaborators
Karolinska Institutet
University of Eastern Finland
INSERM-University of Toulouse
Saarland University
Investigators
Principal Investigator: Miia Kivipelto, MD, PhD Karolinska Institutet

Additional Information:
Publications:
Responsible Party: Miia Kivipelto, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03249688     History of Changes
Other Study ID Numbers: E0750301
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miia Kivipelto, Karolinska Institutet:
Lifestyle intervention
Medical food
Randomized controlled trial
Prodromal Alzheimer's disease
Prevention
Intervention
Multidomain
Multimodal

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders