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Alzheimer’s Drug Discovery Foundation: Program to Accelerate Clinical Trials

Grant Amount: Up to $3 Million
Deadline: Letter of Intent Due February 5, 2021
Category: Health Sciences; Alzheimer's,
Additional Information
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The Alzheimer’s Drug Discovery Foundation welcomes Letters of Intent for its Program to Accelerate Clinical Trials (PACT).

The goal of the program is to increase the number of innovative pharmacologic interventions tested in clinical studies for Alzheimer’s disease and related dementias.

In particular, the PACT program will fund:

Early Stage Human Clinical Trials — Including phase 0 micro- or sub-therapeutic-dosing studies; phase 1 trials in healthy subjects; and biomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effects.

Regulatory Studies — Including non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture required for investigational new drug (IND) and clinical trial authorization (CTA) preclinical packages. Funding is available for preparation of traditional and exploratory IND applications; long-term toxicology studies to enable longer-term dosing in phase 2 trials; and GMP manufacturing and testing of clinical grade drug required to move into phase 2 or phase 3 trials.

Novel, repurposed and repositioned drugs, as well as natural products and devices, will be considered. Therapeutic modalities of interest include small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides, and stem cells. Other non-pharmacologic interventions such as diet, meditation, and exercise will not be considered. Current target areas of interest include epigenetics, inflammation, mitochondria and metabolic function, neuroprotection, proteostasis, synaptic activity and neurotransmitters, vascular function, aging targets (e.g., senescent cells), and other novel targets or pathways that are supported by compelling evidence demonstrating a rational biological connection to the disease process.

Up to $3 million will be awarded based on stage and scope of research. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged.

The RFP is open to researchers and clinicians worldwide at academic medical centers, universities, nonprofits, and biotechnology companies. Existing companies and new spinouts are both eligible, and industry partnerships are strongly encouraged.

Letters of Intent must be received no later than February 5, 2021. Upon review, selected applicants will be invited to submit a full proposal by April 16, 2021.

For complete program guidelines and application instructions, see the Alzheimer’s Drug Discovery Foundation website.

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Alzheimer’s Drug Discovery Foundation: Prevention Pipeline Program

Grant Amount: Up to $3 Million
Deadline: Letter of Intent Due February 5, 2021
Category: Health Sciences; Alzheimer's,
Additional Information
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The Alzheimer’s Drug Discovery Foundation (ADDF) is inviting Letters of Intent for its Prevention Pipeline program. Through the program, awards will be made in support of studies of cognitive symptoms due to health conditions, comparative effectiveness research, and epidemiological studies that probe whether the use or choice of drugs alters the risk for dementia or cognitive decline.

The Prevention Pipeline RFP supports:

Studies of Cognitive Decline and Risk Reduction — Cognitive decline through aging and health conditions has been linked to an increased risk of dementia. ADDF will consider funding programs aimed at preventing and treating these conditions, including menopause-related cognitive symptoms, postoperative delirium and postoperative cognitive decline, mild and/or repetitive traumatic brain injury, and chemotherapy-induced decline. Methods may include epidemiology or clinical trials.

Comparative Effectiveness Research — For many health conditions, physicians have a choice of clinically equivalent drugs. Some of these drugs are being investigated for repurposing to treat Alzheimer’s or related dementias due to their potential disease-modifying properties that go beyond the treatment of their approved disease indication. ADDF will consider funding research to generate an evidence base with respect to whether choices in the routine clinical care of pre-existing conditions could protect against dementia. Priority will be given to the comparison of drugs that are otherwise clinically equivalent for the pre-existing condition. Methods may include randomized trials or epidemiology.

Studies Leveraging the Consortium of Cohorts for Alzheimer’s Prevention Action — Epidemiological studies contribute unmatched information as to whether the risk of dementia or cognitive decline may be influenced by long-term exposure to supplements or medications. However, high-powered studies are needed — ideally with dose, duration, and responder profiles — in order to translate epidemiological research into actionable interventions for testing. Through the CAPA Consortium, ADDF funds collaborative analyses on dementia prevention using a minimum of five longitudinal cohorts, either harmonized or analyzed through parallel analysis of cohorts using a shared analysis script.

Grants of up to $3,000,000 will be awarded for clinical trials based on stage and scope of research.

Eligible applicants include researchers and clinicians at academic medical centers, universities, nonprofits, and biotechnology companies worldwide. Existing companies and new spinouts also are eligible, and industry partnerships are strongly encouraged.

Letters of Intent are due February 5. Upon review, selected applicants will be invited to submit a full proposal by April 16, 2021.

See the Alzheimer’s Drug Discovery Foundation website for complete program details, eligibility criteria, and a link to the application portal.

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Alzheimer’s Drug Discovery Foundation: Drug Development Program Grants

Grant Amount: Up to $600,000 for one year
Deadline: February 5, 2021
Category: Health Sciences; Alzheimer's,
Additional Information
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The Drug Development RFP seeks to support in vivo preclinical studies that advance lead molecules developed for Alzheimer’s disease and related dementias to IND-enabling studies. The proposed studies should be structured to deliver a compound with strong potential for clinical and commercial application.

This funding opportunity prioritizes novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia. For this reason, amyloid targeted approaches and cholinesterase inhibitor proposals will not be considered for this RFP.

Stage of discovery:
– Preclinical pharmacokinetics (PK) and pharmacodynamics (PD) (primarily in wild-type animals to inform dose selection for in vivo efficacy studies), as well as preliminary rodent tolerability studies.
– In vivo efficacy or proof-of-concept studies in animal models of disease or aging, with a focus on measures of direct and indirect markers of target engagement and downstream pharmacologic effects.

Please note: Applications that focus on basic research (including target discovery), assay development, and screening to identify hit compounds are not a priority for this RFP and will be withdrawn.
Please note: IND-enabling work and clinical trials are supported through the Program to Accelerate Clinical Trials (PACT).

Therapeutic modalities: Includes small molecules, biologics, gene therapies, antisense oligonucleotides, and stem cells. Development of novel devices or delivery systems will not be considered for this RFP.

Drug mechanisms or modes of action: Novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia are considered high priority. These include, but are not limited to:
– Epigenetics
– Inflammation
– Mitochondrial & metabolic function
– Neuroprotection
– Proteostasis
– Synaptic activity and neurotransmitters
– Vascular function
– Other mechanisms and modes of action related to the biology of aging (e.g. senescent cells)
– Other novel mechanisms or modes of action that are supported by compelling evidence demonstrating a rational biological connection to the disease process
– Please note: Anti-amyloid approaches (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) and cholinesterase inhibitor proposals will not be considered.

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