Prodromal Alzheimer's DiseaseNCT06105320
COGNIFOOD-Changing the Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study
A study testing LCHF and HCLF in people with Prodromal Alzheimer's Disease and Alzheimer Disease, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
A 2-arm (sequence), 2-period, 2-treatments, single blinded (outcome assessor), randomized crossover-trial (12+12 weeks with immediate contrast) comparing a low-carbohydrate-high-fat diet (LCHF) with a high-carbohydrate-low-fat diet (HCLF) among individuals with prodromal Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Prodromal Alzheimer's Disease, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- LCHF and HCLF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2023to Apr 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to fully understand written and verbal information regarding the study and provide signed and dated informed consent
- Prodromal Alzheimer's disease, as defined by Mild Neurocognitive Disorder due to Alzheimer's disease (AD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and evidence for underlying AD pathology by either:
- Cerebrospinal fluid (CSF) β-amyloid 1-42/1-40x10 ratio < 1 and/or total tau and/or phospho-tau and/or β-amyloid 42 based on local cut-offs OR
- Magnetic Resonance Imaging (MRI) evidence for medial temporal lobe atrophy (MTA score 1 or higher [mesiotemporal atrophy]) OR
- Abnormal Fludeoxyglucose F18 (FDG) Positron Imaging Tomography (PET) and/or Pittsburgh Compound-B (PiB) PET compatible with AD type changes.
- (When the diagnosis prodromal AD is confirmed from medical record, no cognitive testing or renewed assessment of biological AD-pathology is needed for fulfilling this criterion.)
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- Montreal Cognitive Assessment (MoCa) ≥20.
- Availability of a study partner with sufficient contact with the participant, willing and able to give follow-up information on the participant as well as supporting the participant throughout the study.
- Self-reported expected motivation and ability to prepare most weakly meals according to given instructions, with support from the study partner.
- Accept plant-based food, plus food from at least one of the following categories: A. Fish; B. Meat; C. Eggs and dairy
- Ability to reliably undergo a cognitive test in Swedish
Who cannot join
- Major Neurocognitive Disorder (dementia) according to DSM-5
- Body-mass Index (BMI) < 18 or BMI > 35
- Diagnosed Diabetes Mellitus.
- Ongoing treatment with Metformin, Glucagon-Like Peptide 1 (GLP-1)-analog, or Sodium-Glucose Transport Protein 2 (SGLT-2)-inhibitors
- Diagnosed Familial Hypercholesterolemia
- Untreated or unstable Hypertension
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- Alcohol or Substance abuse (current or within 2 years)
- A concomitant serious disease (e.g., cancer, or major psychiatric disorder or other neurological disorder than AD) as judged by study physician
- Major depression or Suicidal ideations (current or within 2 years)
- History of Stroke or Myocardial infarction during the last 5 years.
- Subjects with brain MRI (or CT) scan clinically significant infarct, intracranial macro bleeding, mass lesion or Normal Pressure Hydrocephalus. Those subjects with an MRI scan demonstrating minimal white matter changes (Fazekas scale for white matter lesions classification of 2 or below) and up to 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.
- Participation in any other intervention trial within 30 days (or, if applicable, 5 half-lives of the relevant drug if longer) before baseline and along the study period.
- Any planned changes in cognitive enhancers (e.g., ginkgo, cholinesterase inhibitors), statins, antidepressants, sleeping pills, supplements like medium-chain triglycerides, or any medication expected to influence cognitive function. Such medications are accepted if taken on a stable dose ≥3 months prior to baseline assessment and should, if possible, remain on the same dose during the study. Unplanned changes that take place within the study do not imply exclusion but should be registered in the case report form (CRF).
- Deviations from habitual diet within 1 month before study start. A carbohydrate-restricted or fat-restricted diet, as well as any time-restricted eating, is accepted as habitual diet if stable (and the participant is open to change).
Trial locations and contacts
1 site in 1 country.
Jakob Norgren, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Solna
Clara Arvidsson, RD, clara.arvidsson@regionstockholm.se
About this study
Official title: COGNIFOOD-Investigating the Therapeutic Potential of Changing the Dietary Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study
A 2-arm (sequence), 2-period, 2-treatments, single blinded (outcome assessor), randomized crossover-trial (12+12 weeks with immediate contrast) comparing a low-carbohydrate-high-fat diet (LCHF) with a high-carbohydrate-low-fat diet (HCLF) among individuals with prodromal Alzheimer's disease.
Read the detailed description
The impact of macronutritional composition on cognitive health is not fully understood. On one hand, the World Health Organization (WHO) guidelines propose a limit of total fat intake at 30% of total energy intake (E%), implying that carbohydrates provide at least 50 E%. On the other hand, some pilot studies on ketogenic diets (strict carbohydrate restriction, ≤10 E%) have shown promising results-while liberal carbohydrate restriction has not been investigated in a clinical trial among individuals with Alzheimer's disease or mild cognitive impairment (MCI). It is unclear how important the metabolic state ketosis is for driving potential effects of ketogenic diets on cognitive health outcomes, and our previous observational analyses suggest that even macronutritional changes in the non-ketogenic range might impact cognitive function-although estimated effects differed between sub-samples. This pilot study evaluates the potential of liberal carbohydrate restriction, alternatively fat restriction, as targets for future large scale trials. Participants must be diagnosed with prodromal Alzheimer's disease, which means MCI in combination with biologically validated Alzheimer-pathology-but absence of dementia.
The aim of this trial is to generate a contrast within participants regarding a diet parameter of special interest: the carbohydrate/fat-ratio (CFr). In a randomized order, participants will be exposed to 12 weeks with a low CFr diet (LCHF) and 12 weeks with a high CFr diet (HCLF). In LCHF, sustained ketosis is not an aim but transient mild ketosis may appear in some participants. The following strategies will be used to enhance adherence:
- A mandatory supportive study partner.
- Delivery of one daily meal.
- Delivery of some key ingredients for self-prepared meals.
- Individualized guidance by a dietitian, with consideration of preferred protein sources and complexity of cooking.
Beyond a dichotomized comparison between the diet phases, the study is expected to generate data for a substantial number of observational panel analyses where individual continuous CFr-levels assessed at 5 timepoints may be used as the predictor variable. Those CFr-data will be assessed in parallel with health outcomes including neurodegenerative biomarkers in blood, metabolic biomarkers, and Continous Glucose Monitoring (CGM). Cognitive performance is measured only at 3 timepoints to minimize learning effects. The sample size is adapted to assess feasibility and trends in health outcomes. Due to the limited statistical power there is a considerable risk for type-II errors; therefore, p-values >0.05 should not be interpreted as absence of a clinically meaningful effect in this pilot. Effect modification will be explored by one pre-specified stratification: 1. Apolipoprotein E (APOE) genotypes epsilon-3/4 and 4/4; 2. All other APOE-genotypes.
A cross-over design with immediate contrast (no "wash-out" period) is applied, since it is not possible to define a wash-out value of CFr or reliably keep all participants on a particular CFr between the diet periods. Period 1 (and 2) may have a carry-over effect from pre-study CFr and period 2 may have a carry-over effect from period 1. Primary comparisons against baseline are at the end of each period (weeks 12 \& 24) when carry-over effects are assumed to be relatively low.
- Conditions
- Prodromal Alzheimer's Disease, Alzheimer Disease, Mild Cognitive Impairment, Neurocognitive Disorders
- Being tested
- LCHF, HCLF
- Keywords
- Cognitive health, Cognition, Dementia prevention, Macronutrients
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCHFOther
Also called Non-ketogenic carbohydrate restriction
A diet intervention with the following macronutrient targets:
Carbohydrates: 10-25 E%; Fat 50-70 E%; Protein: 20-25 E%; Alcohol 0-5 E%
HCLFOther
Also called A fat-restricted diet compatible with official dietary guidelines
A diet intervention with the following macronutrient targets:
Carbohydrates: 50-60 E%; Fat 25-30 E%; Protein: 15-20 E%; Alcohol 0-5 E%
| Study group | Role | What they receive |
|---|---|---|
| 1: LCHF-HCLF | Active comparator | LCHF (12 weeks) followed by HCLF (12 weeks) with immediate contrast (no "wash-out" period) Receives: Other: LCHF; Other: HCLF |
| 2: HCLF-LCHF | Active comparator | HCLF (12 weeks) followed by LCHF (12 weeks) with immediate contrast (no "wash-out" period) Receives: Other: LCHF; Other: HCLF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants that are randomized within 1 year from start of recruitment, or time to reach 40 randomized participants if reached within <1 year.
Measured: 1 year from recruitment start
Adherence
Self-reported carbohydrate/fat-ratio (CFr) from 7-day food record:
Intra-individual difference in CFr (log-transformed) between the diet treatments (mean Period 1 [week 6 \&12] vs. mean Period 2 [week 18 \& 24], reversed by arm) expressed as standard deviations of the baseline distribution.
Measured: Week 0, 6, 12, 18, 24
Retention Rate
The proportion of those randomized who complete the 12-week and 24-week follow-up with data on both a. Self-reported carbohydrate/fat-ratio; b. Secondary outcomes
Measured: Until the end of data collection
Secondary outcomes (5)
Global Cognition
Mean of z-scores (higher=better) from 13 sub-tests of a modified Neuropsychological Test Battery (NTB), subsequently z-transformed. Sources of sub-tests include Consortium to Establish a Registry for Alzheimer's Disease (CERAD) test battery and Wechsler Memory Scale (WMS).
- CERAD 10-word List Learning
- CERAD 10-word Delayed Recall
- CERAD 10-word Recognition
- WMS-Verbal Immediate (story)
- WMS-Verbal Delayed (story)
- WMS-Digit Span
- WMS-Visual Paired Associates
- Category Fluency
- CERAD Constructional Praxis
- CERAD Constructional Praxis Recall
- Letter Digit Substitution Test
- Trail Making Test A
- Trail Making Test B
Measured: Week 0, 12, 24
Amyloid β-42/40
Ratio between β-Amyloid concentrations in blood.
Measured: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 weeks (w) vs. ∆0-24 w, reversed by arm.
Phospho-Tau (pTau) 181/231/217
pTau concentrations in blood.
Measured: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 w vs. ∆0-24 w, reversed by arm.
Neurofilament Light (NFL)
NFL concentrations in blood.
Measured: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 w vs. ∆0-24 w, reversed by arm.
Glial Fibrillary Acidic Protein (GFAP)
GFAP concentrations in blood.
Measured: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 w vs. ∆0-24 w, reversed by arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prodromal Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fingers Brain Health Institute, Karolinska Institutet, af Jochnick Foundation
- Responsible party
- Principal investigator, Anne Börjesson-Hanson, Karolinska University Hospital
- Investigators
- Anne Börjesson-Hanson, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105320
- Sponsor's protocol ID
- COGNIFOOD-Pilot
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this is a feasibility study with limited statistical power for analyses on health outcomes, there is no prospective plan to share individual participant data (IPD). This may be reconsidered if feasibility can be established and data sharing can be scientifically, ethically, and legally justified.
Publications
Norgren J, Sindi S, Sandebring-Matton A, Ngandu T, Kivipelto M, Kareholt I. The Dietary Carbohydrate/Fat-Ratio and Cognitive Performance: Panel Analyses in Older Adults at Risk for Dementia. Curr Dev Nutr. 2023 May 7;7(6):100096. doi: 10.1016/j.cdnut.2023.100096. eCollection 2023 Jun.
PubMed 37275847Norgren J, Sindi S, Matton A, Kivipelto M, Kareholt I. APOE-Genotype and Insulin Modulate Estimated Effect of Dietary Macronutrients on Cognitive Performance: Panel Analyses in Nondiabetic Older Adults at Risk of Dementia. J Nutr. 2023 Dec;153(12):3506-3520. doi: 10.1016/j.tjnut.2023.09.016. Epub 2023 Sep 29.
PubMed 37778510
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGNIFOOD-Investigating the Therapeutic Potential of Changing the Dietary Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study
- ClinicalTrials.gov ID
- NCT06105320
- Acronym / sponsor ID
- COGNIFOOD-Pilot
- Conditions
- Prodromal Alzheimer's Disease, Alzheimer Disease, Mild Cognitive Impairment, Neurocognitive Disorders
- Keywords
- Cognitive health, Cognition, Dementia prevention, Macronutrients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Fingers Brain Health Institute, Karolinska Institutet, af Jochnick Foundation
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Oct 2023 (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.
A 2-arm (sequence), 2-period, 2-treatments, single blinded (outcome assessor), randomized crossover-trial (12+12 weeks with immediate contrast) comparing a low-carbohydrate-high-fat diet (LCHF) with a high-carbohydrate-low-fat diet (HCLF) among individuals with prodromal Alzheimer's disease.
Detailed description
The impact of macronutritional composition on cognitive health is not fully understood. On one hand, the World Health Organization (WHO) guidelines propose a limit of total fat intake at 30% of total energy intake (E%), implying that carbohydrates provide at least 50 E%. On the other hand, some pilot studies on ketogenic diets (strict carbohydrate restriction, ≤10 E%) have shown promising results-while liberal carbohydrate restriction has not been investigated in a clinical trial among individuals with Alzheimer's disease or mild cognitive impairment (MCI). It is unclear how important the metabolic state ketosis is for driving potential effects of ketogenic diets on cognitive health outcomes, and our previous observational analyses suggest that even macronutritional changes in the non-ketogenic range might impact cognitive function-although estimated effects differed between sub-samples. This pilot study evaluates the potential of liberal carbohydrate restriction, alternatively fat restriction, as targets for future large scale trials. Participants must be diagnosed with prodromal Alzheimer's disease, which means MCI in combination with biologically validated Alzheimer-pathology-but absence of dementia.
The aim of this trial is to generate a contrast within participants regarding a diet parameter of special interest: the carbohydrate/fat-ratio (CFr). In a randomized order, participants will be exposed to 12 weeks with a low CFr diet (LCHF) and 12 weeks with a high CFr diet (HCLF). In LCHF, sustained ketosis is not an aim but transient mild ketosis may appear in some participants. The following strategies will be used to enhance adherence:
- A mandatory supportive study partner.
- Delivery of one daily meal.
- Delivery of some key ingredients for self-prepared meals.
- Individualized guidance by a dietitian, with consideration of preferred protein sources and complexity of cooking.
Beyond a dichotomized comparison between the diet phases, the study is expected to generate data for a substantial number of observational panel analyses where individual continuous CFr-levels assessed at 5 timepoints may be used as the predictor variable. Those CFr-data will be assessed in parallel with health outcomes including neurodegenerative biomarkers in blood, metabolic biomarkers, and Continous Glucose Monitoring (CGM). Cognitive performance is measured only at 3 timepoints to minimize learning effects. The sample size is adapted to assess feasibility and trends in health outcomes. Due to the limited statistical power there is a considerable risk for type-II errors; therefore, p-values >0.05 should not be interpreted as absence of a clinically meaningful effect in this pilot. Effect modification will be explored by one pre-specified stratification: 1. Apolipoprotein E (APOE) genotypes epsilon-3/4 and 4/4; 2. All other APOE-genotypes.
A cross-over design with immediate contrast (no "wash-out" period) is applied, since it is not possible to define a wash-out value of CFr or reliably keep all participants on a particular CFr between the diet periods. Period 1 (and 2) may have a carry-over effect from pre-study CFr and period 2 may have a carry-over effect from period 1. Primary comparisons against baseline are at the end of each period (weeks 12 \& 24) when carry-over effects are assumed to be relatively low.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: LCHF-HCLF | Active comparator | Other: LCHF, Other: HCLFLCHF (12 weeks) followed by HCLF (12 weeks) with immediate contrast (no "wash-out" period) |
| 2: HCLF-LCHF | Active comparator | Other: LCHF, Other: HCLFHCLF (12 weeks) followed by LCHF (12 weeks) with immediate contrast (no "wash-out" period) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to fully understand written and verbal information regarding the study and provide signed and dated informed consent
- Prodromal Alzheimer's disease, as defined by Mild Neurocognitive Disorder due to Alzheimer's disease (AD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and evidence for underlying AD pathology by either:
- (When the diagnosis prodromal AD is confirmed from medical record, no cognitive testing or renewed assessment of biological AD-pathology is needed for fulfilling this criterion.)
- Montreal Cognitive Assessment (MoCa) ≥20.
- Availability of a study partner with sufficient contact with the participant, willing and able to give follow-up information on the participant as well as supporting the participant throughout the study.
Key exclusion criteria (16 listed)
- Major Neurocognitive Disorder (dementia) according to DSM-5
- Body-mass Index (BMI) < 18 or BMI > 35
- Diagnosed Diabetes Mellitus.
- Ongoing treatment with Metformin, Glucagon-Like Peptide 1 (GLP-1)-analog, or Sodium-Glucose Transport Protein 2 (SGLT-2)-inhibitors
- Diagnosed Familial Hypercholesterolemia
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 |
|---|---|---|
| LCHFAlso: Non-ketogenic carbohydrate restrictionA diet intervention with the following macronutrient targets: Carbohydrates: 10-25 E%; Fat 50-70 E%; Protein: 20-25 E%; Alcohol 0-5 E% | Other | 1: LCHF-HCLF, 2: HCLF-LCHF |
| HCLFAlso: A fat-restricted diet compatible with official dietary guidelinesA diet intervention with the following macronutrient targets: Carbohydrates: 50-60 E%; Fat 25-30 E%; Protein: 15-20 E%; Alcohol 0-5 E% | Other | 1: LCHF-HCLF, 2: HCLF-LCHF |
Primary outcome
Recruitment Rate
Time frame: 1 year from recruitment start
Number of participants that are randomized within 1 year from start of recruitment, or time to reach 40 randomized participants if reached within <1 year.
Adherence
Time frame: Week 0, 6, 12, 18, 24
Self-reported carbohydrate/fat-ratio (CFr) from 7-day food record: Intra-individual difference in CFr (log-transformed) between the diet treatments (mean Period 1 [week 6 \&12] vs. mean Period 2 [week 18 \& 24], reversed by arm) expressed as standard deviations of the baseline distribution.
Retention Rate
Time frame: Until the end of data collection
The proportion of those randomized who complete the 12-week and 24-week follow-up with data on both a. Self-reported carbohydrate/fat-ratio; b. Secondary outcomes
5 secondary outcomes
Global Cognition
Time frame: Week 0, 12, 24
Amyloid β-42/40
Time frame: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 weeks (w) vs. ∆0-24 w, reversed by arm.
Phospho-Tau (pTau) 181/231/217
Time frame: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 w vs. ∆0-24 w, reversed by arm.
Neurofilament Light (NFL)
Time frame: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 w vs. ∆0-24 w, reversed by arm.
Glial Fibrillary Acidic Protein (GFAP)
Time frame: Week 0, 6, 12, 18, 24; Primary comparison: ∆0-12 w vs. ∆0-24 w, reversed by arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Background: PubMed 37275847Norgren J, Sindi S, Sandebring-Matton A, Ngandu T, Kivipelto M, Kareholt I. The Dietary Carbohydrate/Fat-Ratio and Cognitive Performance: Panel Analyses in Older Adults at Risk for Dementia. Curr Dev Nutr. 2023 May 7;7(6):100096. doi: 10.1016/j.cdnut.2023.100096. eCollection 2023 Jun.
- Background: PubMed 37778510Norgren J, Sindi S, Matton A, Kivipelto M, Kareholt I. APOE-Genotype and Insulin Modulate Estimated Effect of Dietary Macronutrients on Cognitive Performance: Panel Analyses in Nondiabetic Older Adults at Risk of Dementia. J Nutr. 2023 Dec;153(12):3506-3520. doi: 10.1016/j.tjnut.2023.09.016. Epub 2023 Sep 29.
- Individual participant dataSharing planned: No. Since this is a feasibility study with limited statistical power for analyses on health outcomes, there is no prospective plan to share individual participant data (IPD). This may be reconsidered if feasibility can be established and data sharing can be scientifically, ethically, and legally justified.
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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.
Jakob Norgren, PhD contact
Anne Börjesson-Hanson, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCHF and HCLF in people with Prodromal Alzheimer's Disease and Alzheimer Disease, run by Karolinska University Hospital 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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Börjesson-Hanson, MD, PhD (+46-8-123 858 68, anne.borjesson-hanson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 1 year from recruitment start). 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 NCT06105320, which also lists 2 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 27 Oct 2023.