Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407499314703 Date of Approval: 18/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The AFRICA-FINGERS Project
Official scientific title Multi-National Implementation of Multimodal Strategies to promote Healthy Brain Ageing in Sub-Saharan Africa (The AFRICA-FINGERS Project)
Brief summary describing the background and objectives of the trial Background Dementia burden in Sub-Saharan Africa (SSA) can be addressed via evidence-based modifiable risk factor reduction. By 2050, the worldwide prevalence of dementia, driven by population aging, is estimated to triple from 55 million currently, with >60% of cases residing in LMICs, particularly in the poorest regions such as Sub-Saharan Africa (SSA). The increased incidence of dementia in SSA will add substantial social, health and economic challenges in these resource-limited areas. Alzheimer’s disease (AD), the most common cause of dementia, has no widely available curative treatments. Mixed dementias, e.g. AD and vascular, are most common, especially in individuals of African ancestry, who also have a high prevalence of stroke. The progression of brain pathology is ≈15-25 years before dementia onset, providing a window for prevention. Evidence indicates that modifiable risk factor reduction at the population level (e.g. physical and cognitively active lifestyle; smoking cessation; healthy diet and vascular/metabolic risk management) could substantially impact brain health and prevent or delay dementia onset. The 2019 World Health Organization (WHO) Guidelines for risk reduction of cognitive decline and dementia stress the importance of addressing multiple risk factors simultaneously, given the limited efficacy of single interventions. Yet, no systematic community-based dementia prevention programmes exist for SSA. Objectives The overarching aim of this project is to reduce the risk of cognitive impairment and dementia through a brain health promotion initiative encompassing urban and rural sites among established psycho-socio-demographic phenotyped cohorts in Kenya and Nigeria
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AFRICA FINGERS
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 30/04/2029
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group FINGER based multimodal lifestyle intervention 1. Monitoring and Management of vascular and metabolic risk factors with 6 individual sessions per participant over 24 months. 2. Group-based physical exercises (up to 90mins). This will comprise of African traditional dance with music sessions 1-2x/week per participant over the 24 moths. 3. Cognitive training activities: each participant will have 6 group sessions, Individual sessions 1X/week in the first six months, a cognitive training break for 3 - 6 months, and 2 group sessions and individual sessions 1X/week over the last 12 months. 4. Nutritional counselling: each participant will have 4 group sessions and 1 individual session over the first 6 months, 1 group session and 1 individual session over months 6 - 12, and 2 group sessions and 1 individual session over the last 12 months. 24 months The FINGER-based multi-domain lifestyle intervention, which will be delivered in the structured multimodal intervention group, comprises four structured lifestyle components: diet, physical activity, cognitive stimulation, and management of cardiovascular/metabolic risk factors, subject to co-design by the community stakeholders. The dietary intervention will most likely be based on the relevant national nutrition guidelines and will include 3 individual counselling sessions and 7 group sessions, led by a trained nutritionist/dietitian. The physical activity intervention will be administered under the close supervision of a physiotherapist/professional trainer and may include an individually tailored and progressive exercise Programme of resistance and balance training in group sessions (at least once/week), complemented with independent aerobic exercise (at least once/week), as this regime has shown good adherence in the Japanese Multidomain Lifestyle Intervention trial (J-MINT). The cognitive stimulation component will be delivered through easily accessible methods for cognitive training/mental activity These will include learning English or a new language, arts/skill-based interventions – including arts-based therapies leveraging augmented reality, playing traditional games, e.g., local board/card games using skill and/or memory; goal-setting tasks, specifically it may include evidence-based personalized goal-setting and problem-solving cognitive intervention that provides cognitive stimulation and tools for managing individualized functional challenges, thus easily culturally-adaptable The cardiovascular and metabolic risk factor management will be delivered through 6 additional individual appointments with the study physician or the study nurse, during which physical and medical assessments will be conducted and feedback regarding vascular and metabolic risk factors will be provided, together with medical advice and motivational discussions. 300
Control Group Self guided multimodal intervention Healthy lifestyle advice based on national guidelines (every 6 months) 24 months During the assessment visits defined for all participants in the study (baseline, 6-, 12- and 24-months), the self-guided multimodal intervention group will receive relevant health advice and will be recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine without any structured activity. 300 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 50 – 85 years. 2. CAIDE Dementia Risk Score ≥6 points (based on age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity; range 0–14 points). The CAIDE risk score will be calculated based on data already collected as part of the relevant register or newly collected as part of the screening for lifestyle process. 3. Cognitive performance at the mean level or slightly lower than expected for age according to local population norms. The aim of this screening for lifestyle is to exclude individuals with substantial cognitive impairment/dementia, but also high performers, with low likelihood of change over 24 months. The cognitive screening for lifestyle will be based on the IDEA test. 4. Proficiency in the local language i.e. fluency and literacy in English and/or major traditional dialect Swahili (Kiswahili), Igbo or Yoruba 5. Able to consent 6. Any medication affecting cognition must have a stable dose for ≥4 weeks. 1. Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician). IDEA-IADL score ≤10), or high functioning level (IDEA > age-adjusted 70th centile 2. Current or past use of medications for AD or related diseases (e.g., cholinesterase inhibitors, memantine). 3. Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement. 4. Other known significant neurologic disease, including but not limited to Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities. 5. Any other condition affecting safe engagement in the intervention, e.g. malignant disease, major depression, symptomatic cardiovascular disease, revascularization within the previous year. 6. Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation as judged by the study physician. 7. Coincident participation in the active phase of another intervention trial. 8. Severe health conditions/recent surgical or other major procedures preventing safe intervention engagement/ trial participation as judged by study physician (e.g., severe sensory impairment; on-going major psychiatric illness) Exclusion criteria affecting the engagement in the intervention will be evaluated by the study physician for those meeting the cognitive inclusion criteria. Internet literacy will be also evaluated to ensure that each participant is willing to engage with the remote components of the intervention. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 31/05/2024 Imperial College London Research Ethics Committee ICREC
Ethics Committee Address
Street address City Postal code Country
South Kensington Campus London SW7 2AZ, UK London SW7 2AZ United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/08/2024 Aga Khan University Institutional Scientific Ethics Review Committee ISERC
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue off Limuru Road Nairobi Kenya Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/08/2024 NNAMDI AZIKIWE UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Perm Site, along ifite gate, Opposite Garba square, Anambra, Nigeria Anambra P.M.B 502 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neuropsychological performance measures using the modified Neuropsychological Test Battery composite z score. The Composite score will be an average of the three composite cognitive domain scores of the executive function, processing speed, and memory subtests. Baseline at 0 months, during at 12 months, and post intervention at 24 months
Secondary Outcome 1. Composite scores for A-NTB including memory, executive function, and processing speed domains (based on FINGER, “composite cognitive domain scores”). 2. Change in functioning outcomes measured using the Instrumental Activities of Daily Living (IDEA-ADL) questionnaire and healthy lifestyle changes measured using the Healthy Lifestyle Index, a composite score based on exercise, diet, lifestyle cardiovascular risk factors, social and cognitive activity, BMI, waist, waist/hip ratio, hip and head circumference, mid-upper arm circumference (MUAC), blood pressure, lipid profile and glucose metabolism. 3. Change in individual cardiovascular and metabolic risk factors as well as cardiovascular morbidity and mortality like incident cardiovascular disease (e.g., myocardial infarction, angina pectoris, transient ischemic attack, stroke, peripheral artery disease). 4. Change in diet measured using the FINGER healthy diet index, nutrients, and food intake. 5. Self-reported and objectively measured levels of physical activity, physical functioning, depression, anxiety, stress, sleep, resilience, flourishing, health-related quality of life, and utilization of healthcare resources We will also evaluate exploratory outcomes on potential effects of intervention on brain MRI (e.g., volumetry, cortical thickness, white matter lesions, cerebral blood flow, cerebrovascular reactivity), cerebral glucose metabolism on FDG-PET, amyloid and tau accumulation via CSF biomarkers, and AD-related blood markers (e.g. amyloid, tau, neurofilament light polypeptide). We will conduct a neuroimaging biomarker sub-study (following the African Dementia Imaging protocol) and Retinal imaging (following the protocol for the Deep and Frequent Phenotyping study). There will be subgroup analyses by e.g., age, sex, APOE ε4 carrier status, baseline cognitive and functional level, and adherence to the intervention. We will monitor liver functioning using blood ALAT, ASAT, GGT. Baseline at 0 months, during at 6 and 12 months, and post intervention at 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The College of Medicine University of Lagos and the affiliate Lagos University Teaching Hospital University Road, Akoka, Yaba Local Government, Lagos, Nigeria. Lagos Nigeria
Research Center for Ageing Cognition and Psychological Health in Nnamdi Azikiwe University Awka Perm Site, along ifite gate, Opposite Garba square, Anambra, Nigeria Anambra Nigeria
The Aga Khan University Brain and Mind Institute in collaboration with the Cancer Research Center Clinical Research Unit UC Building, 3rd Parklands Avenue, Off Limuru Road, Nairobi, Kenya Nairobi 00100 Kenya
Aga Khan University Kaloleni Rabai Community Health and Demographic Surveillance System UC Building, 3rd Parklands Avenue, Off Limuru Road, Nairobi, Kenya Kilifi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council MRC Caxton House Tothill Street London London SW1H 9NA United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University kenya 3rd Parklands avenue of Limuru Road Nairobi Kenya Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ChiUdeh Momoh chinedu.momoh@aku.edu +447975599498 3rd Parklands Avenue off Limuru Road Nairobi Kenya
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan University
Role Name Email Phone Street address
Principal Investigator Miia Kivipelto m.kivipelto@imperial.ac.uk +4402033110257 Charing Cross Campus Laboratory Wing 10th floor St Dunstans Road London
City Postal code Country Position/Affiliation
London W6 8RP United Kingdom Imperial College London
Role Name Email Phone Street address
Public Enquiries Chi Udeh Momoh chinedu.momoh@aku.edu +447975599498 3rd Parklands Avenue Limuru Road Nairobi Kenya
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan University
Role Name Email Phone Street address
Scientific Enquiries Chi Udeh Momoh chinedu.momoh@aku.edu +447975599498 3rd Parklands Avenue Limuru Road Nairobi Kenya
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan university
Role Name Email Phone Street address
Public Enquiries Adedoyin Ogunyemi aoogunyemi@cmul.edu.ng +2348063068858 University Road, Akoka, Yaba Local Government, Lagos, Nigeria.
City Postal code Country Position/Affiliation
Lagos Nigeria University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Adedoyin Ogunyemi aoogunyemi@cmul.edu.ng +2348063068858 University Road, Akoka, Yaba Local Government, Lagos, Nigeria
City Postal code Country Position/Affiliation
Lagos Nigeria University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Valentine Ucheagwu va.ucheagwu@unizik.edu.ng +2348066640319 Perm Site, along ifite gate, Opposite Garba square, Anambra, Nigeria
City Postal code Country Position/Affiliation
Anambra Nigeria Nnamdi Azikiwe University Awka
Role Name Email Phone Street address
Scientific Enquiries Miia Kivipelto m.kivipelto@imperial.ac.uk +4402033110257 Charing Cross Campus Laboratory Wing 10th floor St Dunstans Road London
City Postal code Country Position/Affiliation
London W6 8RP United Kingdom Imperial College London
Role Name Email Phone Street address
Public Enquiries Gloria Chemutai gloria.chemutai@aku.edu +254724087384 3rd Parklands avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan University
Role Name Email Phone Street address
Public Enquiries Rachel Maina maina.rachel@gmail.com +254726439624 3rd Parklands Avenue off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan University
Role Name Email Phone Street address
Public Enquiries Laz Eze laz.eze@gbhi.org +2348020815150 Perm Site, along ifite gate, Opposite Garba square, Anambra, Nigeria
City Postal code Country Position/Affiliation
Anambra Nigeria Nnamdi Azikiwe University Awka
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The investigator shall permit direct access to participants’ records and source documents for the purposes of monitoring, auditing, or inspection by the Sponsor, authorized representatives of the Sponsor, RECs/IRBs, and institutional grant auditing body. The investigators and study site staff will comply with the requirements of the Kenyan Data Protection Act 2019 and GDPR concerning the collection, storage, processing, and disclosure of personal information and will uphold the Acts’ core principles. Should the investigator wish to assign the study records to another party or move them to another location, written agreement must be obtained from the Sponsor in the form of a Data Transfer Agreement (DTA) or/and Material Transfer Agreement (MTA). Samples and data will be de-identified (devoid of personal identifiers) in the event of being sent to external organizations (Recipient) receiving these samples. All Recipients will be subject to an AKU’s Material Transfer Agreement and Data Transfer Agreement. These will outline the responsibilities of each party in the transfer of any de-identified materials and data. Recipients will agree to use the materials and data exclusively for the approved purposes without exception; the material and data will be used by the Recipient in compliance with Kenyan Data Transfer Act (2019), HTA, GCP, GDPR and HIPPA standards. Data may eventually be hosted on the Alzheimer's Disease Data Initiative (ADDI) platform after embargo period hence, in such a case, we will request for a DTA with ADDI. Upon identifying these parties, an amendment to this protocol will be submitted to ISERC with Data Transfer Agreements in place between AKU and relevant third parties. Participants will be informed prior to biosample collection that their samples will be de-identified and retained by BMI indefinitely and that study investigators will work with third parties to conduct research testing and may share their de-identified samples and/or data with them Study Protocol After 2029 or study completion The chief investigator shall permit direct access to participants’ records and source documents for the purposes of monitoring, auditing, or inspection by the Sponsor, authorized representatives of the Sponsor, RECs/IRBs, and institutional grant auditing body. The study investigators will work with third parties, including companies, research institutions, and collaborators to conduct further research testing and may share the participants' de-identified samples and/or data with them. However, no data will be shared or samples shipped outside of AKU without first obtaining approval from ISERC.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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