Alzheimer DiseaseNCT03585907
Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline
A study testing MAD and MIND in people with Alzheimer Disease and Cognitive Impairment, run by Johns Hopkins University.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment
- What is being tested?
- MAD and MIND
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2019to 1 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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)
- fasting total cholesterol > 300 mg/dL
- fasting LDL cholesterol > 200 mg/dL
- Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
- Body mass index < 18.5
- History of ischemic or hemorrhagic stroke
- History of nephrolithiasis
- History of myocardial infarction or known coronary artery disease
- Acute pancreatitis
- Multiple food allergies or strict dietary requirements
- Any other concerns about nutritional status (e.g., recent unexplained weight loss, difficulty swallowing)
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Being tested
- MAD, MIND
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MADDietary supplement
A high fat, low carbohydrate diet
MINDDietary supplement
A combination of the Mediterranean and DASH diets
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet (MAD) | Experimental | A diet that can produce ketones Receives: 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. Receives: Dietary Supplement: MIND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Tested via venipuncture or buccal swab at baseline/week-0
Secondary outcomes (4)
Change in Trail Making Test
This is a timed test of processing speed and executive functioning. Faster time to completion and fewer errors indicate better processing speed and executive functioning. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Measured: Baseline, week-6, week-12
Change in Prospective Memory Test
This is a test of remembering to ask that a borrowed item be returned. The possible scores range from 0 (no cues needed to remember to ask) to 4 (4 cues needed to remember to ask). More cues required indicates worse prospective memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Measured: Baseline, week-6, week-12
Change in Geriatric Anxiety Scale
This is a self-report measure of symptoms of anxiety in older persons. It is rated on a 0 (not at all) to 3 (all of the time) scale. Scores range from 0-90, with higher scores indicating more anxiety. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Measured: Baseline, week-6, week-12
Change in Geriatric Depression Scale
This is a self-report measure of symptoms of depression in older persons. Items are rated as yes/no. Scores range from 0-30, with higher scores indicating more depression. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Measured: Baseline, week-6, week-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start2 Sep 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585907
- Sponsor's protocol ID
- IRB00175761
- Status last verified
- Oct 2019
- First submitted
- 21 Jun 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT03585907
- Acronym / sponsor ID
- IRB00175761
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 2 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet (MAD) | Experimental | Dietary Supplement: MADA diet that can produce ketones |
| MIND diet | Active comparator | Dietary Supplement: MINDMediterranean-DASH Intervention for Neurodegenerative Delay (MIND). A diet that has been indicated to be helpful in preventing or decreasing cognitive decline. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MADA high fat, low carbohydrate diet | Dietary supplement | Modified Atkins Diet (MAD) |
| MINDA combination of the Mediterranean and DASH diets | Dietary supplement | MIND diet |
Primary outcome
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.
4 secondary outcomes
Change in Trail Making Test
Time frame: Baseline, week-6, week-12
Change in Prospective Memory Test
Time frame: Baseline, week-6, week-12
Change in Geriatric Anxiety Scale
Time frame: Baseline, week-6, week-12
Change in Geriatric Depression Scale
Time frame: Baseline, week-6, week-12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MAD and MIND in people with Alzheimer Disease and Cognitive Impairment, run by Johns Hopkins University.
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 6 inclusion and 25 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: withdrawn, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Memory Functioning Questionnaire (MFQ) (time frame: Baseline/week-0, week-6, completion/week-12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.