Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline

NCT03585907 | Withdrawn DMC

• 1 other identifier: IRB00175761
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess if/how dietary interventions (i.e., the Modified Atkins Diet (MAD) and/or the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)) might prevent, delay onset, alleviate symptoms, or otherwise alter the course of subjective cognitive decline (SCD) likely due to Alzheimer's disease (AD). We hypothesize that participants will tolerate both diets well and that the MAD will result in more favorable changes in cognition and other functioning.

Conditions

Alzheimer Disease; Cognitive Impairment

Outcome Measures

Primary Outcomes (6)

• Change in Memory Functioning Questionnaire (MFQ)

  This is a self-report assessment of cognitive decline. It is rated on a 1-7 scale, with 1 indicating "major problems" and 7 indicating "no problems." It includes 8 sections, each including 1-18 sub-questions. It will be assessed by comparing changes in scores between groups and across time (12 weeks).

  Baseline/week-0, week-6, completion/week-12

• Change in Loewenstein-Acevedo Scales of Semantic Interference and Learning (LASSI-L)

  This is an assessment of verbal learning and memory for lists of 15 words. More words learned and remembered indicate better learning and memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).

  Baseline/week-0, week-6, completion/week-12

• Change in Para-Rodriguez Short-term Visual Memory Binding Test (SVMBT)

  This is an assessment of visual recognition memory for shapes and colors. More accurate recognition indicates better recognition memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).

  Baseline/week-0, week-6, completion/week-12

• Change in Ketone levels

  This is detected in urine and measured in mg/dL, with higher levels indicating greater production of ketones and greater adherence to the MAD diet. Adherence will be assessed by percent of participants in the MAD group in at least moderate ketosis (\>40 mg/dl) at 3 or more follow-up visits.

  Checked by the participant daily, for 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks) and checked by the study staff at each study visit (i.e., baseline/week-0, week-3, week-6, and completion/week-12)

• MIND Diet Score

  This is assessed by dietitian review of participants daily food logs. Scores range from 0 (not at all adherent) to 15 (perfectly adherent). Any score greater than 9 is considered adherent. It will be assessed by percent of participants in the MIND group with scores of at least 9 at 3 or more follow-up visits.

  12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks)

• ApoE epsilon 4 status

  This is a genetic marker of Alzheimer's disease risk. It will be coded as positive (one or more epsilon 4 alleles) or negative (no epsilon 4 alleles). It will be evaluated by stratifying the sample by the presence of at least one ε4 allele and conditioning the efficacy analyses by this variable.

  Tested via venipuncture or buccal swab at baseline/week-0

Secondary Outcomes (4)

• Change in Trail Making Test

  Baseline, week-6, week-12

• Change in Prospective Memory Test

  Baseline, week-6, week-12

• Change in Geriatric Anxiety Scale

  Baseline, week-6, week-12

• Change in Geriatric Depression Scale

  Baseline, week-6, week-12

Other Outcomes (1)

• Change in Cognitive decline concern questionnaire

  Baseline, week-6, week-12

Study Arms (2)

Modified Atkins Diet (MAD)

EXPERIMENTAL

A diet that can produce ketones

Dietary Supplement: MAD

MIND diet

ACTIVE COMPARATOR

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND). A diet that has been indicated to be helpful in preventing or decreasing cognitive decline.

Dietary Supplement: MIND

Interventions

MAD DIETARY_SUPPLEMENT

A high fat, low carbohydrate diet

Modified Atkins Diet (MAD)

MIND DIETARY_SUPPLEMENT

A combination of the Mediterranean and DASH diets

MIND diet

Eligibility Criteria

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

You may qualify if:

• Self-experienced persistent decline in cognitive capacity compared with a previously normal status that is unrelated to an acute event and that is not explained by a psychiatric disorder or neurological disease apart from Alzheimer's disease, medical disorder, medication, or substance use, with the onset of decline no longer than 5 years prior to study participation
• Clinical Dementia Rating (CDR) score equal to 0
• Montreal Cognitive Assessment (MoCA) equal to or greater than 26
• Age 60 years or older
• Personal physician clearance
• Willing to comply with all requirements of the study protocol and provide informed consent

You may not qualify if:

• Diagnosis of mild cognitive impairment (MCI), Alzheimer's disease (AD), or other dementia
• Current psychiatric diagnosis
• Unstable metabolic condition (documented on screening laboratory studies performed within the past year)
• persistent hyponatremia (sodium \< 130 mg/dL twice within the past year)
• severe hypernatremia (sodium \> 150 mg/dL twice within the past year)
• hypoglycemia (glucose \< 50 mg/dL)
• hypocalcemia (albumin-corrected calcium \< 8 mg/dL)
• Type-I diabetes
• Type-2 diabetes requiring any medication other than metformin. (Please note that patients with type-2 diabetes may require medication adjustment if on the very low-carb modified Atkins diet.)
• Liver failure
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or ammonia \> 5x upper limits of normal
• hyperbilirubinemia
• total bilirubin \> 15 mg/dL
• direct bilirubin \> 5 mg/dL
• Hypercholesterolemia (on medication, if needed)

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

mycophenolic adenine dinucleotide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 13, 2018
• Study Start: September 2, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 3, 2019

Record last verified: 2019-10