Multimodal Preventive Trial for Alzheimer's Disease

NCT03249688 | Completed DMC

• 1 other identifier: E0750301
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Prodromal

Keywords

Lifestyle intervention; Medical food; Randomized controlled trial; Prodromal Alzheimer's disease; Prevention; Intervention; Multidomain; Multimodal

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Recruitment rate of participants within a 6 months period

  6 months

• Overall adherence to the intervention

  Overall adherence to the intervention during 6 months

  6 months

• Retention rate

  Retention rate of participants during 6 months

  6 months

Secondary Outcomes (2)

• Adherence to intervention components

  6 months

• Adherence to healthy lifestyle changes

  6 months

Other Outcomes (12)

• Change in Body Mass Index

  6 months

• Change in Hip-waist ratio

  6 months

• Change in blood pressure

  6 months

Study Arms (3)

Control

OTHER

Regular health advice

Other: Regular health advice

Multidomain 1

EXPERIMENTAL

Multidomain lifestyle

Behavioral: Multidomain lifestyle

Multidomain 2

EXPERIMENTAL

Multidomain lifestyle + medical food

Behavioral: Multidomain lifestyle; Dietary Supplement: Medical food

Interventions

Regular health advice OTHER

Routine healthy lifestyle counseling

Control

Multidomain lifestyle BEHAVIORAL

Nutritional guidance, exercise, cognitive training, vascular risk monitoring

Multidomain 1; Multidomain 2

Medical food DIETARY_SUPPLEMENT

Medical food product (Fortasyn Connect)

Multidomain 2

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Eastern Finland: collaborator
• Universität des Saarlandes: collaborator
• University Hospital, Toulouse: collaborator

Study Sites (1)

Karolinska University Hospital

Huddinge, 14186, Sweden

Location

Related Publications (6)

• 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.

  PMID: 25771249 BACKGROUND

• 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.

  PMID: 27767993 BACKGROUND

• 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.

  PMID: 17616482 BACKGROUND

• 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.

  PMID: 23985420 BACKGROUND

• 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.

  PMID: 38961421 DERIVED

• 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.

  PMID: 38812047 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Miia Kivipelto, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2017
• First Posted: August 15, 2017
• Study Start: October 16, 2017
• Primary Completion: December 23, 2019
• Study Completion: December 18, 2020
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)