Cognitive DeclineNCT03145987
Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Older Adults.
A study testing Vitis vinifera extract in people with Cognitive Decline and Neurophysiologic Abnormality, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino".
Trial summary
The increase in life expectancy is associated with a gradual aging of the population so creating new needs arising from this new situation. Memory ability declines with age and memory deficits are regarded as an initial symptom of dementia of Alzheimer's Disease (AD) type, one of the most prevalent cognitive disorders… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Neurophysiologic Abnormality
- What is being tested?
- Vitis vinifera extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 55 years; italian speaking and understanding; no using food supplements for cognitive functioning two weeks before enrolling and during the study period; score > or = 24 at Mini-Mental State Exam (MMSE).
Who cannot join
- age < 55 or > 75 years, or AD or other related disorders, psychiatric or neurological diseases (including aphasia, sensory, motor or visual disturbances which could affect the test results), cancer, coagulation disorders, cardiovascular, lung, kidney, thyroid, liver, gastrointestinal disease or insulin-dependent diabetes, excessive consumption of alcohol or substance abuse/dependence; more than 3 medical hospitalizations last year or subjects taking coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants or any medications for cognitive functioning.
About this study
Official title: A Randomized, Double-blinded, Clinical Trial on Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Healthy Older Adults.
The increase in life expectancy is associated with a gradual aging of the population so creating new needs arising from this new situation. Memory ability declines with age and memory deficits are regarded as an initial symptom of dementia of Alzheimer's Disease (AD) type, one of the most prevalent cognitive disorders in older people. States and scientific community have been called to find preventive strategies acting against the consequent physiological cognitive decline with the aim to attenuate the increase of dementia. Numerous studies have shown that polyphenolic compounds derived from multiple dietary sources, and more specifically the polyphenolic compounds found in grapes (GP), are able to attenuate the cognitive impairment and in reducing neuropathological lesions in the brain in experimental animal models for the study of Alzheimer's Disease (AD) .
In recent years, several in vivo studies have shown that oral administration of polyphenols from grapes improves antioxidant status in the brain and prevents neuronal damage induced by free radicals. The intake of proanthocyanidins, especially in the monomeric form, showed to produce an improvement of cognitive function in an Alzheimer's disorder animal model.
Read more
A randomized, double-blind, placebo-controlled clinical trial was designed by the investigators with the aim to evaluate potential beneficial effects of a Vitis vinifera-based food supplement on cognitive functioning and neuropsychological status in healthy older adults aging 55-75 years.
For the enrollment, mental status was evaluated through the Mini-Mental State Exam, a test able to provide quickly a screen of orientation, providing a rapid screen of recall, language, orientation, registration, attention and calculation. 111 subjects were recruited and, after obtaining the informed consent, successively randomly divided in two groups: Group 1, N = 57 to be treated for 12 weeks with Vitis vinifera extract (verum 250 mg/day); Group 2, N = 54 to be treated for 12 weeks with placebo. Cognitive functioning and neuropsychological status were evaluated at the beginning (before treatment) and a the end of treatment by using Mini Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety Rating Scale (HARS) and Repeatable Battery for the Assessment of Neuropsychological Status.
Read the detailed description
Study design The study was a randomized into a two-group, parallel, placebo-controlled clinical trial to assess the efficacy of a food supplement containing vitis vinifera extract developed for cognitive and neuropsychological functioning in healthy older adults.
Screening Mental status was evaluated through the MMSE, a test able to provide quickly a screen of orientation, providing a rapid screen of recall, language, orientation, registration, attention and calculation. To study the effects on cognitive functioning and neuropsychological status participants were also subjected to the Beck Depression Inventory (BDI) and Hamilton Anxiety Rating Scale (HARS).
At screening (visit 1, day 0) after giving informed consent, subjects underwent medical history, physical examination, and vital signs. All subjects got oral and written information about the study and gave written informed consent to participate before inclusion in the trial. After screening and evaluation of baseline scores, included subjects were randomly allocated to one of two groups treated as follows: Group 1, N = 57 to be treated with Cognigrape capsule (verum 250 mg/day); Group 2, N = 54 to be treated with placebo . Randomisation by blocks of 3 (2 + 1) was double-blinded. Successive blocks were balanced by 2s. Neither subjects recruited for the study nor investigators were able to differentiate the two different treatments.
The Mini-Mental State Examination is composed of 12 items exploring through 22 trials verbal and performance, 7 cognitive functions: temporal and spatial orientation; immediate memory; attention and calculation; recall memory; language; praxia visuo-constructive. The administration requires a time ranging from 5 to 15 minutes. The score is corrected for age and education; the threshold for the purposes of enrollment in the study is set at a score ≥ 24. The MMSE score between 18 and 24 is an indication of a compromised moderate to mild, while a score of 25 is considered borderline, from 26 to 30 is indicative of normality cognitive. For this reason a score limit of 24 including masked potential light cognitive decline in healthy adults was chosen.
Beck Depression Inventory is a self-report instrument measuring the severity of depression. The Beck Depression Inventory (BDI) Short Form, a prominently and frequently cited, self-reported measure of depression was used. The 13-item questionnaire assesses 4 major components of depression: behavioral, affective, cognitive, and physiological. Numerical values assigned to each statement range from 0 to 3 indicating increasing severity. According to Beck's clinical criteria, a score between 8 and 15 indicates moderate depression and 16 severe depression.
Questionnaire is composed of in 21 questions with multiple choice response suitable to investigate the presence of depressive symptoms; aspects investigated by the test are: sadness, pessimism, sense of failure, dissatisfaction, guilty, free expectation, self-disappointment, self-accusation, suicidal ideas, crying, irritability, indecision, doubt, social withdrawal, devaluation of its image body, work efficiency decrease, sleep disturbance, fatigue, decreased appetite, weight loss, somatic concerns, loss of libido. The questionnaire has been administered immediately before the beginning (Day 0) and at the end of treatment (after 12 weeks).
Hamilton Anxiety Rating Scale is a scale evaluating anxiety through the investigation of 15 different areas (such as insomnia, mood, somatic symptoms). Each of the 15 areas is composed of a minimum of 3 to a maximum of 8 items to each of which is given a score from 0 to 6, depending on the severity of symptoms. Subsequently the total value is calculated for each area, using a score of 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe) points, based on the overall severity of symptoms investigating each specific area. The total score, which has been called "whole", is calculated by adding the points of each of the 15 areas surveyed. The rating of the scale may vary from 0 to 56. A total score around 18 is considered indicative of a pathological state.
Repeatable Battery for the Assessment of Neuropsychological Status is a quick and complete neuropsychological battery, consisting of two forms ( "A" and "B") associated with identical difficulty degrees, each divided into 12 subtests administered to evaluate 5 different cognitive domains: attention, language, visuospatial/constructional abilities immediate memory and delayed memory.
Cognitive-neuropsychological assessment was performed at baseline (o day) and after the 12 weeks of treatment period. Measures included MMSE, BDI, HARS, RBANS.
- Conditions
- Cognitive Decline, Neurophysiologic Abnormality
- Being tested
- Vitis vinifera extract, Placebo
- Keywords
- Cognitive functioning, Neuropsychological status, Vitis vinifera
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitis vinifera extractDietary supplement
Also called Cognigrape®
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Vitis vinifera extract | Experimental | Vitis vinifera extract 250 mg/day orally administered for 12 weeks. Receives: Dietary Supplement: Vitis vinifera extract |
| Placebo | Placebo comparator | Placebo orally administered once a day for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination
Mini Mental state Examination is composed of 12 items exploring through 22 trials verbal and performance, 7 cognitive functions: temporal and spatial orientation; immediate memory; attention and calculation; recall memory; language; praxia visuo-constructive.
Measured: Up to 12 weeks
Beck Depression Inventory
It is a self-report instrument measuring the severity of depression. The Beck Depression Inventory (BDI) Short Form was used. BDI is a prominently and frequently cited, self-reported measure of depression. The 13-item questionnaire assesses 4 major components of depression: behavioral, affective, cognitive, and physiological. Numerical values assigned to each statement range from 0 to 3 indicating increasing severity. According to Beck's clinical criteria, a score between 8 and 15 indicates moderate depression and 16 severe depression.
Measured: Up to 12 weeks.
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale is a scale evaluating anxiety through the investigation of 15 different areas (such as insomnia, mood, somatic symptoms). Each of the 15 areas is composed of a minimum of 3 to a maximum of 8 items to each of which is given a score from 0 to 6, depending on the severity of symptoms. Subsequently the total value is calculated for each area, using a score of 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe) points, based on the overall severity of symptoms investigating each specific area. The total score, which has been called "whole", is calculated by adding the points of each of the 15 areas surveyed. The rating of the scale may vary from 0 to 56. A total score around 18 is considered indicative of a pathological state.
Measured: Up to 12 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status
Repeatable Battery for the Assessment of Neuropsychological Status is a quick and complete neuropsychological battery, consisting of two forms ( "A" and "B") associated with identical difficulty degrees, each divided into 12 subtests administered to evaluate 5 different cognitive domains: attention, language, visuospatial/constructional abilities immediate memory and delayed memory.
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startJul 2016
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Randomized, double-blinded, placebo controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Umberto Alecci, MD, Principal investigator, Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145987
- Sponsor's protocol ID
- PhCT-3
- Status last verified
- Jun 2018
- First submitted
- 5 May 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreescu C, Belnap BH, Rollman BL, Houck P, Ciliberti C, Mazumdar S, Shear MK, Lenze EJ. Generalized anxiety disorder severity scale validation in older adults. Am J Geriatr Psychiatry. 2008 Oct;16(10):813-8. doi: 10.1097/JGP.0b013e31817c6aab.
PubMed 18827227Asha Devi S, Sagar Chandrasekar BK, Manjula KR, Ishii N. Grape seed proanthocyanidin lowers brain oxidative stress in adult and middle-aged rats. Exp Gerontol. 2011 Nov;46(11):958-64. doi: 10.1016/j.exger.2011.08.006. Epub 2011 Aug 16.
PubMed 21871550Assuncao M, de Freitas V, Paula-Barbosa M. Grape seed flavanols, but not Port wine, prevent ethanol-induced neuronal lipofuscin formation. Brain Res. 2007 Jan 19;1129(1):72-80. doi: 10.1016/j.brainres.2006.10.044. Epub 2006 Dec 6.
PubMed 17156755Fremont L, Belguendouz L, Delpal S. Antioxidant activity of resveratrol and alcohol-free wine polyphenols related to LDL oxidation and polyunsaturated fatty acids. Life Sci. 1999;64(26):2511-21. doi: 10.1016/s0024-3205(99)00209-x.
PubMed 10403511He Q, Yang SY, Wang W, Wu ZJ, Ma HL, Lu Y. Proanthocyanidins affects the neurotoxicity of Abeta25-35 on C57/bl6 mice. Eur Rev Med Pharmacol Sci. 2016;20(4):679-84.
PubMed 26957270Oliboni LS, Dani C, Funchal C, Henriques JA, Salvador M. Hepatoprotective, cardioprotective, and renal-protective effects of organic and conventional grapevine leaf extracts on Wistar rat tissues. An Acad Bras Cienc. 2011 Dec;83(4):1403-11. doi: 10.1590/s0001-37652011000400027.
PubMed 22146965Shukitt-Hale B, Carey A, Simon L, Mark DA, Joseph JA. Effects of Concord grape juice on cognitive and motor deficits in aging. Nutrition. 2006 Mar;22(3):295-302. doi: 10.1016/j.nut.2005.07.016. Epub 2006 Jan 18.
PubMed 16412610Wang YJ, Thomas P, Zhong JH, Bi FF, Kosaraju S, Pollard A, Fenech M, Zhou XF. Consumption of grape seed extract prevents amyloid-beta deposition and attenuates inflammation in brain of an Alzheimer's disease mouse. Neurotox Res. 2009 Jan;15(1):3-14. doi: 10.1007/s12640-009-9000-x. Epub 2009 Feb 10.
PubMed 19384583Hartman RE, Shah A, Fagan AM, Schwetye KE, Parsadanian M, Schulman RN, Finn MB, Holtzman DM. Pomegranate juice decreases amyloid load and improves behavior in a mouse model of Alzheimer's disease. Neurobiol Dis. 2006 Dec;24(3):506-15. doi: 10.1016/j.nbd.2006.08.006. Epub 2006 Sep 28.
PubMed 17010630Hill NL, Mogle J, Wion R, Munoz E, DePasquale N, Yevchak AM, Parisi JM. Subjective Cognitive Impairment and Affective Symptoms: A Systematic Review. Gerontologist. 2016 Dec;56(6):e109-e127. doi: 10.1093/geront/gnw091. Epub 2016 Jun 23.
PubMed 27342440Novitski J, Steele S, Karantzoulis S, Randolph C. The Repeatable Battery for the Assessment of Neuropsychological Status effort scale. Arch Clin Neuropsychol. 2012 Mar;27(2):190-5. doi: 10.1093/arclin/acr119. Epub 2012 Jan 25.
PubMed 22277124Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.
PubMed 11735772Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.
PubMed 9845158Rezai-Zadeh K, Shytle D, Sun N, Mori T, Hou H, Jeanniton D, Ehrhart J, Townsend K, Zeng J, Morgan D, Hardy J, Town T, Tan J. Green tea epigallocatechin-3-gallate (EGCG) modulates amyloid precursor protein cleavage and reduces cerebral amyloidosis in Alzheimer transgenic mice. J Neurosci. 2005 Sep 21;25(38):8807-14. doi: 10.1523/JNEUROSCI.1521-05.2005.
PubMed 16177050Scola G, Conte D, Spada PW, Dani C, Vanderlinde R, Funchal C, Salvador M. Flavan-3-ol compounds from wine wastes with in vitro and in vivo antioxidant activity. Nutrients. 2010 Oct;2(10):1048-59. doi: 10.3390/nu2101048. Epub 2010 Oct 11.
PubMed 22253995
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Clinical Trial on Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Healthy Older Adults.
- ClinicalTrials.gov ID
- NCT03145987
- Acronym / sponsor ID
- PhCT-3
- Conditions
- Cognitive Decline, Neurophysiologic Abnormality
- Keywords
- Cognitive functioning, Neuropsychological status, Vitis vinifera
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 May 2017 (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.
The increase in life expectancy is associated with a gradual aging of the population so creating new needs arising from this new situation. Memory ability declines with age and memory deficits are regarded as an initial symptom of dementia of Alzheimer's Disease (AD) type, one of the most prevalent cognitive disorders in older people. States and scientific community have been called to find preventive strategies acting against the consequent physiological cognitive decline with the aim to attenuate the increase of dementia. Numerous studies have shown that polyphenolic compounds derived from multiple dietary sources, and more specifically the polyphenolic compounds found in grapes (GP), are able to attenuate the cognitive impairment and in reducing neuropathological lesions in the brain in experimental animal models for the study of Alzheimer's Disease (AD) .
In recent years, several in vivo studies have shown that oral administration of polyphenols from grapes improves antioxidant status in the brain and prevents neuronal damage induced by free radicals. The intake of proanthocyanidins, especially in the monomeric form, showed to produce an improvement of cognitive function in an Alzheimer's disorder animal model.
A randomized, double-blind, placebo-controlled clinical trial was designed by the investigators with the aim to evaluate potential beneficial effects of a Vitis vinifera-based food supplement on cognitive functioning and neuropsychological status in healthy older adults aging 55-75 years.
For the enrollment, mental status was evaluated through the Mini-Mental State Exam, a test able to provide quickly a screen of orientation, providing a rapid screen of recall, language, orientation, registration, attention and calculation. 111 subjects were recruited and, after obtaining the informed consent, successively randomly divided in two groups: Group 1, N = 57 to be treated for 12 weeks with Vitis vinifera extract (verum 250 mg/day); Group 2, N = 54 to be treated for 12 weeks with placebo. Cognitive functioning and neuropsychological status were evaluated at the beginning (before treatment) and a the end of treatment by using Mini Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety Rating Scale (HARS) and Repeatable Battery for the Assessment of Neuropsychological Status.
Detailed description
Study design The study was a randomized into a two-group, parallel, placebo-controlled clinical trial to assess the efficacy of a food supplement containing vitis vinifera extract developed for cognitive and neuropsychological functioning in healthy older adults.
Screening Mental status was evaluated through the MMSE, a test able to provide quickly a screen of orientation, providing a rapid screen of recall, language, orientation, registration, attention and calculation. To study the effects on cognitive functioning and neuropsychological status participants were also subjected to the Beck Depression Inventory (BDI) and Hamilton Anxiety Rating Scale (HARS).
At screening (visit 1, day 0) after giving informed consent, subjects underwent medical history, physical examination, and vital signs. All subjects got oral and written information about the study and gave written informed consent to participate before inclusion in the trial. After screening and evaluation of baseline scores, included subjects were randomly allocated to one of two groups treated as follows: Group 1, N = 57 to be treated with Cognigrape capsule (verum 250 mg/day); Group 2, N = 54 to be treated with placebo . Randomisation by blocks of 3 (2 + 1) was double-blinded. Successive blocks were balanced by 2s. Neither subjects recruited for the study nor investigators were able to differentiate the two different treatments.
The Mini-Mental State Examination is composed of 12 items exploring through 22 trials verbal and performance, 7 cognitive functions: temporal and spatial orientation; immediate memory; attention and calculation; recall memory; language; praxia visuo-constructive. The administration requires a time ranging from 5 to 15 minutes. The score is corrected for age and education; the threshold for the purposes of enrollment in the study is set at a score ≥ 24. The MMSE score between 18 and 24 is an indication of a compromised moderate to mild, while a score of 25 is considered borderline, from 26 to 30 is indicative of normality cognitive. For this reason a score limit of 24 including masked potential light cognitive decline in healthy adults was chosen.
Beck Depression Inventory is a self-report instrument measuring the severity of depression. The Beck Depression Inventory (BDI) Short Form, a prominently and frequently cited, self-reported measure of depression was used. The 13-item questionnaire assesses 4 major components of depression: behavioral, affective, cognitive, and physiological. Numerical values assigned to each statement range from 0 to 3 indicating increasing severity. According to Beck's clinical criteria, a score between 8 and 15 indicates moderate depression and 16 severe depression.
Questionnaire is composed of in 21 questions with multiple choice response suitable to investigate the presence of depressive symptoms; aspects investigated by the test are: sadness, pessimism, sense of failure, dissatisfaction, guilty, free expectation, self-disappointment, self-accusation, suicidal ideas, crying, irritability, indecision, doubt, social withdrawal, devaluation of its image body, work efficiency decrease, sleep disturbance, fatigue, decreased appetite, weight loss, somatic concerns, loss of libido. The questionnaire has been administered immediately before the beginning (Day 0) and at the end of treatment (after 12 weeks).
Hamilton Anxiety Rating Scale is a scale evaluating anxiety through the investigation of 15 different areas (such as insomnia, mood, somatic symptoms). Each of the 15 areas is composed of a minimum of 3 to a maximum of 8 items to each of which is given a score from 0 to 6, depending on the severity of symptoms. Subsequently the total value is calculated for each area, using a score of 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe) points, based on the overall severity of symptoms investigating each specific area. The total score, which has been called "whole", is calculated by adding the points of each of the 15 areas surveyed. The rating of the scale may vary from 0 to 56. A total score around 18 is considered indicative of a pathological state.
Repeatable Battery for the Assessment of Neuropsychological Status is a quick and complete neuropsychological battery, consisting of two forms ( "A" and "B") associated with identical difficulty degrees, each divided into 12 subtests administered to evaluate 5 different cognitive domains: attention, language, visuospatial/constructional abilities immediate memory and delayed memory.
Cognitive-neuropsychological assessment was performed at baseline (o day) and after the 12 weeks of treatment period. Measures included MMSE, BDI, HARS, RBANS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo controlled study.
| Arm | Type | Receives |
|---|---|---|
| Vitis vinifera extract | Experimental | Dietary Supplement: Vitis vinifera extractVitis vinifera extract 250 mg/day orally administered for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo orally administered once a day for 12 weeks. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age over 55 years; italian speaking and understanding; no using food supplements for cognitive functioning two weeks before enrolling and during the study period; score > or = 24 at Mini-Mental State Exam (MMSE).
Key exclusion criteria (1 listed)
- age < 55 or > 75 years, or AD or other related disorders, psychiatric or neurological diseases (including aphasia, sensory, motor or visual disturbances which could affect the test results), cancer, coagulation disorders, cardiovascular, lung, kidney, thyroid, liver, gastrointestinal disease or insulin-dependent diabetes, excessive consumption of alcohol or substance abuse/dependence; more than 3 medical hospitalizations last year or subjects taking coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants or any medications for cognitive functioning.
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 |
|---|---|---|
| Vitis vinifera extractAlso: Cognigrape® | Dietary supplement | Vitis vinifera extract |
| Placebo | Other | Placebo |
Primary outcome
Mini Mental State Examination
Time frame: Up to 12 weeks
Mini Mental state Examination is composed of 12 items exploring through 22 trials verbal and performance, 7 cognitive functions: temporal and spatial orientation; immediate memory; attention and calculation; recall memory; language; praxia visuo-constructive.
Beck Depression Inventory
Time frame: Up to 12 weeks.
It is a self-report instrument measuring the severity of depression. The Beck Depression Inventory (BDI) Short Form was used. BDI is a prominently and frequently cited, self-reported measure of depression. The 13-item questionnaire assesses 4 major components of depression: behavioral, affective, cognitive, and physiological. Numerical values assigned to each statement range from 0 to 3 indicating increasing severity. According to Beck's clinical criteria, a score between 8 and 15 indicates moderate depression and 16 severe depression.
Hamilton Anxiety Rating Scale
Time frame: Up to 12 weeks.
Hamilton Anxiety Rating Scale is a scale evaluating anxiety through the investigation of 15 different areas (such as insomnia, mood, somatic symptoms). Each of the 15 areas is composed of a minimum of 3 to a maximum of 8 items to each of which is given a score from 0 to 6, depending on the severity of symptoms. Subsequently the total value is calculated for each area, using a score of 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe) points, based on the overall severity of symptoms investigating each specific area. The total score, which has been called "whole", is calculated by adding the points of each of the 15 areas surveyed. The rating of the scale may vary from 0 to 56. A total score around 18 is considered indicative of a pathological state.
Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Up to 12 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status is a quick and complete neuropsychological battery, consisting of two forms ( "A" and "B") associated with identical difficulty degrees, each divided into 12 subtests administered to evaluate 5 different cognitive domains: attention, language, visuospatial/constructional abilities immediate memory and delayed memory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 18827227Andreescu C, Belnap BH, Rollman BL, Houck P, Ciliberti C, Mazumdar S, Shear MK, Lenze EJ. Generalized anxiety disorder severity scale validation in older adults. Am J Geriatr Psychiatry. 2008 Oct;16(10):813-8. doi: 10.1097/JGP.0b013e31817c6aab.
- Background: PubMed 21871550Asha Devi S, Sagar Chandrasekar BK, Manjula KR, Ishii N. Grape seed proanthocyanidin lowers brain oxidative stress in adult and middle-aged rats. Exp Gerontol. 2011 Nov;46(11):958-64. doi: 10.1016/j.exger.2011.08.006. Epub 2011 Aug 16.
- Background: PubMed 17156755Assuncao M, de Freitas V, Paula-Barbosa M. Grape seed flavanols, but not Port wine, prevent ethanol-induced neuronal lipofuscin formation. Brain Res. 2007 Jan 19;1129(1):72-80. doi: 10.1016/j.brainres.2006.10.044. Epub 2006 Dec 6.
- Background: PubMed 10403511Fremont L, Belguendouz L, Delpal S. Antioxidant activity of resveratrol and alcohol-free wine polyphenols related to LDL oxidation and polyunsaturated fatty acids. Life Sci. 1999;64(26):2511-21. doi: 10.1016/s0024-3205(99)00209-x.
- Background: PubMed 26957270He Q, Yang SY, Wang W, Wu ZJ, Ma HL, Lu Y. Proanthocyanidins affects the neurotoxicity of Abeta25-35 on C57/bl6 mice. Eur Rev Med Pharmacol Sci. 2016;20(4):679-84.
- Background: PubMed 22146965Oliboni LS, Dani C, Funchal C, Henriques JA, Salvador M. Hepatoprotective, cardioprotective, and renal-protective effects of organic and conventional grapevine leaf extracts on Wistar rat tissues. An Acad Bras Cienc. 2011 Dec;83(4):1403-11. doi: 10.1590/s0001-37652011000400027.
- Background: PubMed 16412610Shukitt-Hale B, Carey A, Simon L, Mark DA, Joseph JA. Effects of Concord grape juice on cognitive and motor deficits in aging. Nutrition. 2006 Mar;22(3):295-302. doi: 10.1016/j.nut.2005.07.016. Epub 2006 Jan 18.
- Background: PubMed 19384583Wang YJ, Thomas P, Zhong JH, Bi FF, Kosaraju S, Pollard A, Fenech M, Zhou XF. Consumption of grape seed extract prevents amyloid-beta deposition and attenuates inflammation in brain of an Alzheimer's disease mouse. Neurotox Res. 2009 Jan;15(1):3-14. doi: 10.1007/s12640-009-9000-x. Epub 2009 Feb 10.
- Background: PubMed 17010630Hartman RE, Shah A, Fagan AM, Schwetye KE, Parsadanian M, Schulman RN, Finn MB, Holtzman DM. Pomegranate juice decreases amyloid load and improves behavior in a mouse model of Alzheimer's disease. Neurobiol Dis. 2006 Dec;24(3):506-15. doi: 10.1016/j.nbd.2006.08.006. Epub 2006 Sep 28.
- Background: PubMed 27342440Hill NL, Mogle J, Wion R, Munoz E, DePasquale N, Yevchak AM, Parisi JM. Subjective Cognitive Impairment and Affective Symptoms: A Systematic Review. Gerontologist. 2016 Dec;56(6):e109-e127. doi: 10.1093/geront/gnw091. Epub 2016 Jun 23.
- Background: PubMed 22277124Novitski J, Steele S, Karantzoulis S, Randolph C. The Repeatable Battery for the Assessment of Neuropsychological Status effort scale. Arch Clin Neuropsychol. 2012 Mar;27(2):190-5. doi: 10.1093/arclin/acr119. Epub 2012 Jan 25.
- Background: PubMed 11735772Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.
- Individual participant dataSharing planned: No
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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.
Umberto Alecci, MD principal investigator
Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.
Questions about this trial
What is this clinical trial studying?
A study testing Vitis vinifera extract in people with Cognitive Decline and Neurophysiologic Abnormality, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino".
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jun 2018. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mini Mental State Examination (time frame: Up to 12 weeks). The study lists 4 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 NCT03145987, which also lists 21 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 26 Jun 2018.