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Alzheimer Disease; ProdromalMIND-ADminiNCT03249688

Multimodal Preventive Trial for Alzheimer's Disease

A study testing Regular health advice, Multidomain lifestyle and Medical food in people with Alzheimer Disease; Prodromal, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer Disease; Prodromal
What is being tested?
Regular health advice, Multidomain lifestyle and Medical food
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteSweden
Study dates
16 Oct 2017to 18 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • MRI evidence for medial temporal lobe atrophy (MTA score 1 or higher) OR
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  • Abnormal FDG PET and/or PiB PET compatible with AD type change
  • 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
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Huddinge, 14186

Other trials in Sweden

About this study

Official title: Multimodal Preventive Trial for Alzheimer's Disease (MIND-ADmini Pilot Trial)

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

Read the 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).

Being tested
Regular health advice, Multidomain lifestyle, Medical food
Keywords
Lifestyle intervention, Medical food, Randomized controlled trial, Prodromal Alzheimer's disease, Prevention, Intervention, Multidomain, Multimodal
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular health adviceOther

    Routine healthy lifestyle counseling

  • Multidomain lifestyleBehavioural

    Nutritional guidance, exercise, cognitive training, vascular risk monitoring

  • Medical foodDietary supplement

    Medical food product (Fortasyn Connect)

Study groups in NCT03249688
Study groupRoleWhat they receive
ControlOtherRegular health advice
Receives: Other: Regular health advice
Multidomain 1ExperimentalMultidomain lifestyle
Receives: Behavioral: Multidomain lifestyle
Multidomain 2ExperimentalMultidomain lifestyle + medical food
Receives: Behavioral: Multidomain lifestyle; Dietary Supplement: Medical food

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Recruitment rate of participants within a 6 months period

    Measured: 6 months

  2. Overall adherence to the intervention

    Overall adherence to the intervention during 6 months

    Measured: 6 months

  3. Retention rate

    Retention rate of participants during 6 months

    Measured: 6 months

Secondary outcomes (2)

  1. Adherence to intervention components

    Intervention arms only

    Measured: 6 months

  2. Adherence to healthy lifestyle changes

    All arms

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start16 Oct 2017
  3. Primary completion23 Dec 2019
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249688
Sponsor's protocol ID
E0750301
Acronym
MIND-ADmini
Status last verified
Sep 2021
First submitted
8 Jul 2017
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

    PubMed 25771249

  • Cummings J, Scheltens P, McKeith I, Blesa R, Harrison JE, Bertolucci PH, Rockwood K, Wilkinson D, Wijker W, Bennett DA, Shah RC. Effect Size Analyses of Souvenaid in Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1131-1139. doi: 10.3233/JAD-160745.

    PubMed 27767993

  • Dubois B, Feldman HH, Jacova C, Dekosky ST, Barberger-Gateau P, Cummings J, Delacourte A, Galasko D, Gauthier S, Jicha G, Meguro K, O'brien J, Pasquier F, Robert P, Rossor M, Salloway S, Stern Y, Visser PJ, Scheltens P. Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 2007 Aug;6(8):734-46. doi: 10.1016/S1474-4422(07)70178-3.

    PubMed 17616482

  • van Wijk N, Broersen LM, de Wilde MC, Hageman RJ, Groenendijk M, Sijben JW, Kamphuis PJ. Targeting synaptic dysfunction in Alzheimer's disease by administering a specific nutrient combination. J Alzheimers Dis. 2014;38(3):459-79. doi: 10.3233/JAD-130998.

    PubMed 23985420

  • Levak N, Lehtisalo J, Thunborg C, Westman E, Andersen P, Andrieu S, Broersen LM, Coley N, Hartmann T, Irving GF, Mangialasche F, Ngandu T, Pantel J, Rosenberg A, Sindi S, Soininen H, Solomon A, Wang R, Kivipelto M. Nutrition guidance within a multimodal intervention improves diet quality in prodromal Alzheimer's disease: Multimodal Preventive Trial for Alzheimer's Disease (MIND-ADmini). Alzheimers Res Ther. 2024 Jul 3;16(1):147. doi: 10.1186/s13195-024-01522-8.

    PubMed 38961421

  • Thunborg C, Wang R, Rosenberg A, Sindi S, Andersen P, Andrieu S, Broersen LM, Coley N, Couderc C, Duval CZ, Faxen-Irving G, Hagman G, Hallikainen M, Hakansson K, Kekkonen E, Lehtisalo J, Levak N, Mangialasche F, Pantel J, Rydstrom A, Stigsdotter-Neely A, Wimo A, Ngandu T, Soininen H, Hartmann T, Solomon A, Kivipelto M. Integrating a multimodal lifestyle intervention with medical food in prodromal Alzheimer's disease: the MIND-ADmini randomized controlled trial. Alzheimers Res Ther. 2024 May 30;16(1):118. doi: 10.1186/s13195-024-01468-x.

    PubMed 38812047

Questions about this trial

What is this clinical trial studying?

A study testing Regular health advice, Multidomain lifestyle and Medical food in people with Alzheimer Disease; Prodromal, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249688, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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