Therapeutic Diets in Alzheimer's Disease
NCT03860792, Not applicable, Completed, University of Kansas Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Therapeutic Diets in Alzheimer's Disease | ClinicalTrials.gov |
| NCT number | NCT03860792 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 84 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Kansas Medical Center | ClinicalTrials.gov |
| Conditions | Alzheimer Disease | ClinicalTrials.gov |
| Interventions | Ketogenic Diet, Therapeutic Lifestyles Changes Diet | ClinicalTrials.gov |
| First posted | 2019-03-04 | ClinicalTrials.gov |
| Last updated | 2026-09-08 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Cognitive Performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11) | Baseline, 12 Weeks | Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance on the Mini-Mental State Exam (MMSE) | Baseline, 12 Weeks | Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a range of 0 to 30 points where higher scores indicate better cognitive performance. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance on the Logical Memory Test 1 (LMT1) | Baseline, 12 Weeks | The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory, with a scaled score range of 1 to 19, where higher scores indicate better performance. A short story is orally presented, and the examinee is asked to recall the story immediately. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance on the Logical Memory Test 2 (LMT2) | Baseline, 12 weeks | The amount of information retained after a delay following the initial introduction of the material to be learned. The result is a scaled score range of 1 to 19, where higher scores indicate better performance. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance on the Stroop Word Test | Baseline, 12 Weeks | Number of items named per the rules of this test as assessed by a psychometrician. It determines a raw score value of 0 to 100, with higher values indicating better performance. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance on the Stroop Color Test | Baseline, 12 weeks | Number of items generated per the rules of the test as assessed by a psychometrician. It determines a raw score value of 0 to 100, with higher values indicating better performance. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Performance on the Stroop Color-Word Test | Baseline, 12 weeks | Number of items generated per the rules of the test as assessed by a psychometrician. It determines a raw score value of 0 to 100, with higher values indicating better performance. | ClinicalTrials.gov |
| Secondary | Change in Clinical Dementia Rating (CDR) | Baseline, 12 Weeks | The Clinical Dementia Rating is a 5-point scale (CDR 0, 0.5, 1, 2, and 3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. CDR 0 indicates no dementia and higher values indicate more severe dementia. The scores of all six domains are averaged to form a global CDR score. Change in score from baseline to 3 months will be assessed. | ClinicalTrials.gov |
| Secondary | Change in Frontal Lobe Concentration of N-Acetylaspartate (NAA) | Baseline, 12 Weeks | Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner. | ClinicalTrials.gov |
| Secondary | Change in Frontal Lobe Concentration of Glutamate Plus Glutamine (Glx) | Baseline, 12 weeks | Concentration of cerebral glutamate plus glutamine (Glx) is measured using magnetic resonance spectroscopy in a 3T clinical scanner. | ClinicalTrials.gov |
| Secondary | Change in Blood Platelet COX/CS Vmax | Baseline, 6 Weeks, 12 Weeks | Cytochrome c oxidase activity of blood platelets will be determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm, referenced to the citrate synthase activity | ClinicalTrials.gov |
| Other | Change in Blood Ketone Levels Induced by Ketogenic Diet | Baseline, 12 Weeks | We will measure serum beta-hydroxybutyrate levels as determined by Quest Diagnostics. | ClinicalTrials.gov |
| Other | Proportion of Reported Days Positive for Urinary Ketone Production | Reported days for all the days in the intervention, from the Baseline Visit to the 12-Week Visit | Participant measured urine ketone status using Ketostix (Bayer, Germany) on days collected and reported. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)