Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Johns Hopkins University
- Primary Endpoint
- Change in Memory Functioning Questionnaire (MFQ)
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
Specific aims are to 1) to establish the feasibility of implementing the MAD in older adults with subjective cognitive decline (SCD) likely due to AD, 2) to examine whether changes in participants' cognition, mood, or other functioning are more favorable in patients using the MAD than in patients using the MIND diet, 3) to assess the role of Apolipoprotein E (ApoE) epsilon 4 genotype in response to the MAD in individuals with SCD. We hypothesize that 1) participants will be able to adhere to and tolerate the MAD and the MIND, determined by review of patients' food records and urine ketone production, 2) participants who adhere to the MAD will demonstrate a more favorable change on neuropsychological tests than participants on the MIND diet, and 4) the neuropsychological effects of the MAD will be greatest in those participants without a ε4 allele of the ApoE gene.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Memory Functioning Questionnaire (MFQ)
Time Frame: Baseline/week-0, week-6, completion/week-12
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).
Change in Loewenstein-Acevedo Scales of Semantic Interference and Learning (LASSI-L)
Time Frame: Baseline/week-0, week-6, completion/week-12
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).
Change in Para-Rodriguez Short-term Visual Memory Binding Test (SVMBT)
Time Frame: Baseline/week-0, week-6, completion/week-12
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).
Change in Ketone levels
Time Frame: 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)
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.
MIND Diet Score
Time Frame: 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks)
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.
ApoE epsilon 4 status
Time Frame: Tested via venipuncture or buccal swab at baseline/week-0
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.
Secondary Outcomes
- 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)